Atrial Fibrillation (AF)ACE-AFNCT07424690
Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation
A study testing Catheter Ablation for Atrial Fibrillation, Optimized Medical Therapy for Atrial Fibrillation and Implantable Loop Recorder (ILR) in people with Atrial Fibrillation (AF) and Atrial Fibrillation Ablation, run by Karolinska University Hospital at 2 sites in Sweden.
Trial summary
ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure. Read more about this study
- Who is it for?
- Ages 78 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Elderly
- What is being tested?
- Catheter Ablation for Atrial Fibrillation, Optimized Medical Therapy for Atrial Fibrillation and Implantable Loop Recorder (ILR)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 2 sitesSweden
- Study dates
- 5 Oct 2026to 15 Sep 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 78 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥78 years.
- ECG-documented atrial fibrillation.
- AF type: paroxysmal, persistent, or longstanding persistent AF.
- Suitable candidate for catheter ablation according to ESC guidelines.
- Charlson's comorbidity index ≤7.
Who cannot join
- Left atrial (LA) dimension >55 mm, based on echocardiography within the previous year.
- Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.
- Severe valvular heart disease (per ESC definitions) or congenital heart disease.
- Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.
- Contraindication to oral anticoagulation.
- AF due to a reversible cause.
Show all 10Show fewer
- Medical condition likely to limit survival to <12 months.
- Unable or unwilling to provide informed consent.
- History of non-compliance with medical therapy.
- BMI <18 or >37 kg/m².
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Linköping University Hospital
Linköping
Lars O Karlsson, 013100000, lars.o.karlsson@regionstockholm.se
- Recruiting
Karolinska University Hospital
Stockholm
Emmanouil Charitakis, MD, PhD, 0046767877506, emmanouil.charitakis@regionstockholm.se
About this study
Official title: Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study
ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure.
The study compares two established treatment strategies:
Read more
- Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and
- Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care).
Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time.
The study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months:
- a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and
- patient-reported health-related quality of life (HRQoL), measured by the RAND-36 "General Health" domain.
ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.
Read the detailed description
Background and Rationale
Atrial fibrillation (AF) is highly prevalent in very elderly individuals and is associated with substantial morbidity, including stroke, heart failure (HF), recurrent hospitalisations, polypharmacy, frailty, and impaired health-related quality of life (HRQoL). Catheter ablation is an established rhythm-control therapy in AF, but patients aged ≥78 years have been under-represented in randomised trials, and evidence on comparative effectiveness and safety versus optimised medical therapy in this age group remains limited. ACE-AF is designed to address this knowledge gap using a pragmatic randomised strategy design and continuous rhythm monitoring in both arms.
Study Design
ACE-AF is an investigator-initiated, multicentre, parallel-group, open-label randomised controlled trial conducted at seven Swedish university hospitals and collaborating centres in Denmark, Australia and Greece. Participants aged ≥78 years with symptomatic paroxysmal or persistent AF are randomised 1:1 to an ablation-based strategy or to optimised medical therapy without AF ablation.
Randomisation is performed centrally using an electronic system with allocation concealment until assignment, stratified by sex and age group (78-83 vs >83 years).
Study Arms and Interventions
Arm A: Catheter ablation strategy Catheter ablation is performed according to contemporary clinical practice at experienced centres.
Pulmonary vein isolation (PVI) is prioritised as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion, without restriction to a specific technology.
Periprocedural management (imaging, anticoagulation, anaesthesia strategy) follows local standards of care and the study protocol.
Arm B: Optimised medical therapy strategy (no AF ablation) Guideline-directed rate and/or rhythm control tailored to clinical need, including antiarrhythmic drugs and/or cardioversion when appropriate.
AV-node ablation with pacemaker implantation is permitted when clinically indicated, according to standard care.
Treatment optimisation and follow-up adhere to protocol-defined principles and local clinical routines.
Rhythm monitoring (both arms)
All participants receive an implantable loop recorder (ILR) to enable continuous rhythm monitoring, including quantification of AF burden and detection of clinically relevant arrhythmias over time (ILR programming per protocol).
Study Flow and Follow-up
Screening/Baseline (pre-randomisation/visit 1): informed consent; baseline clinical assessment including comorbidity profiling; baseline questionnaires and planned assessments per protocol.
ILR implantation for continuous monitoring will be performed according to protocol-defined timing/workflow between the first and second visit.
Randomisation (1:1): central, concealed allocation; stratified by sex and age group (78-83 vs >83 years).
Intervention phase (visit 2):
Ablation arm: catheter ablation performed as per protocol and site standards. Control arm: initiation/optimisation of medical therapy; AV-node ablation with pacing permitted if clinically indicated.
Follow-up visits: scheduled follow-up visits are performed at approximately 3, 12, 18 and 24 months after randomisation/intervention, with continuous ILR surveillance throughout follow-up. At follow-up, clinical events, adverse events, treatment changes, and patient-reported outcomes are collected according to protocol, and ILR rhythm summaries are reviewed.
Primary Outcomes (two primary endpoints, tested with Holm-Bonferroni multiplicity control.)
The endpoints are evaluated over 24 months after randomisation and controlled for multiplicity using the Holm-Bonferroni procedure:
Composite clinical endpoint: all-cause mortality, stroke, serious bleeding, cardiac arrest, or hospitalisation due to heart failure within 24 months after randomisation.
HRQoL endpoint: effect on HRQoL measured by the RAND-36 "General Health" domain.
Secondary Outcomes
Secondary outcomes include (as specified in the protocol):
AF burden and rhythm outcomes (ILR-derived): AF burden over time, recurrence patterns, and detection of clinically relevant rhythm events.
Healthcare utilisation: hospitalisations and AF/HF-related care contacts.
Patient-reported outcomes: symptom burden and HRQoL using validated instruments (including RAND-36 and additional AF-related questionnaires per protocol).
Safety outcomes: procedure-related and treatment-related complications and serious adverse events.
Treatment pathways: need for cardioversion, medication escalation, AV-node ablation with pacing, and crossover patterns (as applicable).
Exploratory Objectives and Planned Subgroup/Modifier Analyses
Exploratory analyses will examine whether treatment effects differ by baseline characteristics and geriatric domains, including:
Frailty (e.g., Frailty Index and/or Clinical Frailty Scale).
Cognitive status (protocol-defined assessment).
Inflammatory biomarkers and overall comorbidity burden.
Sex (sex-disaggregated reporting and interaction analyses).
AF type (paroxysmal vs persistent).
Imaging substudy (selected Swedish sites): a predefined subgroup (e.g., at Karolinska and Linköping) planned for brain and/or cardiac imaging with MRI and/or CT per protocol to explore mechanistic associations.
Saliva sampling (optional subgroup): in a predefined subgroup, saliva is collected for exploratory biomarker/genetic analyses relevant to ageing and treatment response (separate consent; optional participation).
If subgroup analyses are underpowered, results will be reported as exploratory.
Sample Size and Statistical Considerations
The planned sample size is 282 participants, providing adequate power to detect clinically meaningful differences over 24 months, accounting for crossover and loss to follow-up. Primary analyses are performed according to the intention-to-treat principle. Multiplicity across the two primary endpoints is addressed using a pre-specified Holm-Bonferroni approach.
Safety Oversight
Participant safety is overseen by an independent Data Monitoring Committee (DMC), comprising senior cardiology researchers independent of the study (Professor Eva Swahn, Professor Lars Lund, and Professor Johan Engdahl). Safety monitoring and adverse event reporting are conducted throughout the study according to the protocol.
Ethics, Regulatory, and Data Protection
The study has been approved by the Swedish Ethical Review Authority (Dnr 2025-02305-01; decision date 12 May 2025); amendment approved 19 May 2026 (Dnr 2026-02894-02). Data are pseudonymised and processed in compliance with GDPR, with data captured in an electronic CRF (REDCap).
- Being tested
- Catheter Ablation for Atrial Fibrillation, Optimized Medical Therapy for Atrial Fibrillation, Implantable Loop Recorder (ILR), AV Node Ablation With Pacemaker implantation
- Keywords
- atrial fibrillation, catheter ablation, rhtyhm control, rate control, implantable loop recorder, elderly, Health-related quality of life, Randomized controlled study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation for Atrial FibrillationProcedure or surgery
Also called catheter ablation, pulmonary vein isolation
Catheter ablation for symptomatic atrial fibrillation with pulmonary vein isolation (PVI) prioritized as the primary lesion set. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology), performed under routine standards of care at experienced centres.
Optimized Medical Therapy for Atrial FibrillationDrug
Also called Guideline-directed medical therapy, Rate control, Rhythm control
Guideline-directed rate and/or rhythm control tailored to the participant's clinical condition, including rate-control medications and/or antiarrhythmic drugs and cardioversion when clinically appropriate. AF ablation is not performed as part of this strategy.
Implantable Loop Recorder (ILR)Device
Subcutaneous implantable loop recorder used for continuous rhythm monitoring and quantification of atrial fibrillation burden throughout follow-up. Implanted in all participants according to protocol-defined workflow.
AV Node Ablation With Pacemaker implantationProcedure or surgery
AV node ablation with permanent pacing may be performed when clinically indicated according to routine care, as part of the optimized medical therapy strategy.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation Strategy | Active comparator | Participants randomized to this arm will undergo catheter ablation for atrial fibrillation, with pulmonary vein isolation (PVI) prioritized as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology). Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. Additional medical therapy may be used as clinically indicated according to guideline-based care. Receives: Procedure: Catheter Ablation for Atrial Fibrillation; Drug: Optimized Medical Therapy for Atrial Fibrillation; Device: Implantable Loop Recorder (ILR) |
| Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing | Active comparator | Participants randomized to this arm will receive optimized guideline-directed medical therapy for atrial fibrillation without AF catheter ablation. Treatment may include rate control and/or rhythm control (including antiarrhythmic drugs and/or cardioversion when clinically appropriate). AV node ablation with pacemaker implantation is permitted when clinically indicated according to routine care. Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. Receives: Drug: Optimized Medical Therapy for Atrial Fibrillation; Procedure: AV Node Ablation With Pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization)
First part of the co-primary outcome: Proportion of participants with ≥1 of the following events within 24 months after intervention (visit 2): all-cause death, stroke, serious bleeding, cardiac arrest, or hospitalization for heart failure. Events will be adjudicated per protocol.
Measured: 24 months after intervention (visit 2)
Change in RAND-36 General Health score
Second part of the co-primary outcome: Change from baseline in the RAND-36 "General Health" domain score at 24 months after the intervention (visit 2). Scores range 0-100; higher scores indicate better perceived health. Intention-to-treat. Because HRQoL is undefined after death, scores are not imputed for participants who die before the 24-month assessment; instead, deceased participants are assigned the worst rank (worst-rank / composite estimand, ICH E9(R1)) and the primary comparison uses a rank-based test. Missing data other than death are handled under a missing-at-random assumption with pre-specified sensitivity analyses.
Measured: Baseline to 24 months after intervention (visit 2)
Secondary outcomes (13)
Differences of atrial fibrillation and atrial tachycardia burden (ILR-derived) between groups
Differences in percentage of time in atrial fibrillation and atrial tachycardia ("AF/AT burden") measured by continuous monitoring using an implantable loop recorder (ILR) between randomization groups.
Measured: From date of ILR implantation (intervention day, visit 2) up to 30 months after implantation.
Hospitalizations (all-cause and cardiovascular)
Number of hospital admissions, including cardiovascular/AF-related hospitalizations, collected from clinical records.
Measured: Up to 24 months after intervention
Serious adverse events and treatment-related complications
Serious adverse events (SAEs) and procedure-/treatment-related complications, including ablation-related and device-related complications, recorded and classified per protocol.
Measured: Up to 24 months after intervention
Additional patient-reported outcomes (AF symptoms / disease-specific HRQoL)
Symptom burden and AF-related quality of life assessed using validated questionnaires specified in the protocol (e.g., ASTA and/or AFEQT, as applicable).
Measured: Baseline and follow-up (3, 12, 18) through 24 months after intervention
Changes in Left atrial reservoir strain (LASr)
Left atrial function assessed as reservoir strain (LASr) by deformation imaging (speckle-tracking / deformation tracking, as per protocol). Reported as change from baseline to follow-up. Unit of measure: %
Measured: Up to 12 months after intervention (visit 2)
Cognitive function measured by Montreal Cognitive Assessment (MoCA)
MoCA total score assessed at follow-up visits. Reported as change from baseline
Measured: MoCA scores will be collected and assessed at baseline, 12, 18, and 24 months after intervention (visit 2).
Frailty score assessed by e-Frailty index
Frailty will be assessed using the e-Frailty index at baseline and follow-up. The outcome will be reported as a change in score from baseline to each follow-up time point.
Measured: Up to 24 months after intervention; visit 2 ( 12, 18, and 24 months)
Discrimination of a prediction model for the ACE-AF primary composite outcome
A multivariable prediction model (using baseline clinical variables and AI-derived features) will be developed to predict the time to first occurrence of the ACE-AF primary composite clinical outcome.
Measured: From baseline up to 24 months after intervention (visit 2).
Predictors of differential treatment effect on AF/AT burden
Baseline clinical variables (and AI-derived features, as available) will be evaluated as predictors of differential treatment effect on ILR-derived atrial fibrillation and atrial tachycardia (AF/AT) burden over follow-up.
Measured: From implantation (visit 2) up to 30 months after intervention
Participants with at least one event in the composite neurological endpoint (dementia, stroke, intracranial hemorrhage)
Composite neurological endpoint defined as the first occurrence of any of the following during follow-up:
- Incident dementia
- Stroke (ischemic or hemorrhagic)
- Intracranial hemorrhage (including intracerebral hemorrhage and subarachnoid hemorrhage, per protocol definition) Results will be reported as number and percentage of participants with ≥1 composite event during follow-up.
Measured: Up to 24 months after intervention (visit 2).
Total healthcare costs per participant
Total direct healthcare costs per participant from intervention through follow-up, derived from healthcare utilization data (e.g., hospital inpatient/outpatient visits, procedures, emergency visits) and valued using standard regional/national tariffs per the health-economic analysis plan. Reported as mean/median cost per participant by group.
Measured: Up to 24 months after intervention (visit 2)
All-cause mortality, stroke/TIA, serious bleeding, cardiac arrest, hospitalization due to heart failure analyzed separately
Measured: Up to 24 months after intervention
Incident dementia
Proportion of participants with a new diagnosis of dementia during follow-up, based on predefined diagnostic criteria and/or registry/medical record confirmation.
Measured: Up to 24 months after intervention (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start5 Oct 2026
- Primary completion15 Dec 2031 (estimated)
- Study completion15 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, multicenter, parallel-group randomized controlled trial with 1:1 allocation to two management strategies (catheter ablation vs optimized medical therapy). Open-label due to the nature of the interventions; follow-up through 24 months with continuous ILR monitoring in both arms.
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Sahlgrenska University Hospital, University Hospital, Umeå, Dept of Cardiology, Örebro University Hospital, Sweden, Lund University Hospital, Onassis Cardiac Surgery Centre, Uppsala University Hospital, Royal Adelaide Hospital
- Responsible party
- Principal investigator, Emmanouil Charitakis, Karolinska University Hospital
- Investigators
- Emmanouil Charitakis, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424690
- Sponsor's protocol ID
- 2025-02305-01
- Other IDs
- 2025
- Acronym
- ACE-AF
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results, plus a data dictionary, will be shared with researchers whose proposal is approved by the ACE-AF steering committee, under a signed data-access agreement and controlled access, in compliance with GDPR, Swedish law and the study's ethics approval.
Publications
Hirata S, Okumura Y, Nagashima K, Watanabe R, Yokoyama K, Matsumoto N, Kato T, Fukaya H, Hayashi H, Nakahara S, Shimizu W, Iwasaki YK, Fujimoto Y, Mukai Y, Ejima K, Otsuka T, Suzuki S, Murakami M, Kimura M, Harada M, Koyama J, Yamane T, Tokuda M, Takami M, Shoda M, Harada T, Nakajima I, Hiroshima K, Tanimoto K, Kumagai K, Okada A, Kobayashi H, Watari Y, Hatsuno M, Hayashi T, Tachibana E, Iso K, Sonoda K, Aizawa Y, Fukuoka R, Chikata A, Inoue M, Sakagami S, Minamiguchi H, Makino N, Ichikawa M, Haruta H, Hiro T, Okubo K, Arai M, Arima K, Kihara H, Miyanaga S, Fukuda Y, Oiwa K, Koyama Y, Kurihara T, Akabane M, Ishikawa N, Kusano K, Miyamoto K, Tabuchi H, Shiozawa T, Miyamoto K, Mase H, Murotani K. Catheter Ablation Outcomes and Life Expectancy in Very Elderly Atrial Fibrillation Patients: The REHEALTH AF Study. JACC Clin Electrophysiol. 2026 Feb;12(2):307-321. doi: 10.1016/j.jacep.2025.10.007. Epub 2025 Nov 24.
PubMed 41288543Blomstrom-Lundqvist C, Gizurarson S, Schwieler J, Jensen SM, Bergfeldt L, Kenneback G, Rubulis A, Malmborg H, Raatikainen P, Lonnerholm S, Hoglund N, Mortsell D. Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial. JAMA. 2019 Mar 19;321(11):1059-1068. doi: 10.1001/jama.2019.0335.
PubMed 30874754Akerstrom F, Hutter J, Charitakis E, Tabrizi F, Asaad F, Bastani H, Bourke T, Braunschweig F, Drca N, Englund A, Friberg L, Insulander P, Jonsson AH, Kenneback G, Paul-Nordin A, Sadigh B, Saluveer O, Saygi S, Schwieler J, Svennberg E, Tapanainen J, Turkmen Y, Jensen-Urstad M. Association between catheter ablation of atrial fibrillation and mortality or stroke. Heart. 2024 Jan 10;110(3):163-169. doi: 10.1136/heartjnl-2023-322883.
PubMed 37657914Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7.
PubMed 29757320Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Jung M, Yang PS, Kim D, Sung JH, Jang E, Yu HT, Kim TH, Uhm JS, Pak HN, Lee MH, Joung B. Multimorbidity in atrial fibrillation for clinical implications using the Charlson Comorbidity Index. Int J Cardiol. 2024 Mar 1;398:131605. doi: 10.1016/j.ijcard.2023.131605. Epub 2023 Nov 22.
PubMed 38000669Bahnson TD, Giczewska A, Mark DB, Russo AM, Monahan KH, Al-Khalidi HR, Silverstein AP, Poole JE, Lee KL, Packer DL; CABANA Investigators. Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial. Circulation. 2022 Mar 15;145(11):796-804. doi: 10.1161/CIRCULATIONAHA.121.055297. Epub 2021 Dec 22.
PubMed 34933570Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
PubMed 30874766Santangeli P, Di Biase L, Mohanty P, Burkhardt JD, Horton R, Bai R, Mohanty S, Pump A, Gibson D, Couts L, Hongo R, Beheiry S, Natale A. Catheter ablation of atrial fibrillation in octogenarians: safety and outcomes. J Cardiovasc Electrophysiol. 2012 Jul;23(7):687-93. doi: 10.1111/j.1540-8167.2012.02293.x. Epub 2012 Apr 11.
PubMed 22494628Tabaja C, Younis A, Santangeli P, Madden R, Taigen T, Farwati M, Hayashi K, Braghieri L, Rickard J, Klein BM, Paul A, Dresing TJ, Martin DO, Bhargava M, Kanj M, Sroubek J, Nakagawa H, Saliba WI, Wazni OM, Hussein AA. Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life. J Interv Card Electrophysiol. 2024 Aug;67(5):1083-1092. doi: 10.1007/s10840-023-01659-w. Epub 2023 Oct 17.
PubMed 37848806Tzeis S, Gerstenfeld EP, Kalman J, Saad EB, Shamloo AS, Andrade JG, Barbhaiya CR, Baykaner T, Boveda S, Calkins H, Chan NY, Chen M, Chen SA, Dagres N, Damiano RJ, De Potter T, Deisenhofer I, Derval N, Di Biase L, Duytschaever M, Dyrda K, Hindricks G, Hocini M, Kim YH, la Meir M, Merino JL, Michaud GF, Natale A, Nault I, Nava S, Nitta T, O'Neill M, Pak HN, Piccini JP, Purerfellner H, Reichlin T, Saenz LC, Sanders P, Schilling R, Schmidt B, Supple GE, Thomas KL, Tondo C, Verma A, Wan EY. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2024 Sep;21(9):e31-e149. doi: 10.1016/j.hrthm.2024.03.017. Epub 2024 Apr 8.
PubMed 38597857Marinigh R, Lip GY, Fiotti N, Giansante C, Lane DA. Age as a risk factor for stroke in atrial fibrillation patients: implications for thromboprophylaxis. J Am Coll Cardiol. 2010 Sep 7;56(11):827-37. doi: 10.1016/j.jacc.2010.05.028.
PubMed 20813280Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med. 2013 Nov;274(5):461-8. doi: 10.1111/joim.12114. Epub 2013 Aug 7.
PubMed 23879838Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
PubMed 39210723
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study
- ClinicalTrials.gov ID
- NCT07424690
- Acronym / sponsor ID
- ACE-AF / 2025-02305-01
- Keywords
- atrial fibrillation, catheter ablation, rhtyhm control, rate control, implantable loop recorder, elderly, Health-related quality of life, Randomized controlled study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Sahlgrenska University Hospital, University Hospital, Umeå, Dept of Cardiology, Örebro University Hospital, Sweden, Lund University Hospital, Onassis Cardiac Surgery Centre, Uppsala University Hospital, Royal Adelaide Hospital
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 15 Dec 2031 (estimated)
- Study completion
- 15 Sep 2034 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure.
The study compares two established treatment strategies:
- Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and
- Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care).
Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time.
The study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months:
- a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and
- patient-reported health-related quality of life (HRQoL), measured by the RAND-36 "General Health" domain.
ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.
Detailed description
Background and Rationale
Atrial fibrillation (AF) is highly prevalent in very elderly individuals and is associated with substantial morbidity, including stroke, heart failure (HF), recurrent hospitalisations, polypharmacy, frailty, and impaired health-related quality of life (HRQoL). Catheter ablation is an established rhythm-control therapy in AF, but patients aged ≥78 years have been under-represented in randomised trials, and evidence on comparative effectiveness and safety versus optimised medical therapy in this age group remains limited. ACE-AF is designed to address this knowledge gap using a pragmatic randomised strategy design and continuous rhythm monitoring in both arms.
Study Design
ACE-AF is an investigator-initiated, multicentre, parallel-group, open-label randomised controlled trial conducted at seven Swedish university hospitals and collaborating centres in Denmark, Australia and Greece. Participants aged ≥78 years with symptomatic paroxysmal or persistent AF are randomised 1:1 to an ablation-based strategy or to optimised medical therapy without AF ablation.
Randomisation is performed centrally using an electronic system with allocation concealment until assignment, stratified by sex and age group (78-83 vs >83 years).
Study Arms and Interventions
Arm A: Catheter ablation strategy Catheter ablation is performed according to contemporary clinical practice at experienced centres.
Pulmonary vein isolation (PVI) is prioritised as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion, without restriction to a specific technology.
Periprocedural management (imaging, anticoagulation, anaesthesia strategy) follows local standards of care and the study protocol.
Arm B: Optimised medical therapy strategy (no AF ablation) Guideline-directed rate and/or rhythm control tailored to clinical need, including antiarrhythmic drugs and/or cardioversion when appropriate.
AV-node ablation with pacemaker implantation is permitted when clinically indicated, according to standard care.
Treatment optimisation and follow-up adhere to protocol-defined principles and local clinical routines.
Rhythm monitoring (both arms)
All participants receive an implantable loop recorder (ILR) to enable continuous rhythm monitoring, including quantification of AF burden and detection of clinically relevant arrhythmias over time (ILR programming per protocol).
Study Flow and Follow-up
Screening/Baseline (pre-randomisation/visit 1): informed consent; baseline clinical assessment including comorbidity profiling; baseline questionnaires and planned assessments per protocol.
ILR implantation for continuous monitoring will be performed according to protocol-defined timing/workflow between the first and second visit.
Randomisation (1:1): central, concealed allocation; stratified by sex and age group (78-83 vs >83 years).
Intervention phase (visit 2):
Ablation arm: catheter ablation performed as per protocol and site standards. Control arm: initiation/optimisation of medical therapy; AV-node ablation with pacing permitted if clinically indicated.
Follow-up visits: scheduled follow-up visits are performed at approximately 3, 12, 18 and 24 months after randomisation/intervention, with continuous ILR surveillance throughout follow-up. At follow-up, clinical events, adverse events, treatment changes, and patient-reported outcomes are collected according to protocol, and ILR rhythm summaries are reviewed.
Primary Outcomes (two primary endpoints, tested with Holm-Bonferroni multiplicity control.)
The endpoints are evaluated over 24 months after randomisation and controlled for multiplicity using the Holm-Bonferroni procedure:
Composite clinical endpoint: all-cause mortality, stroke, serious bleeding, cardiac arrest, or hospitalisation due to heart failure within 24 months after randomisation.
HRQoL endpoint: effect on HRQoL measured by the RAND-36 "General Health" domain.
Secondary Outcomes
Secondary outcomes include (as specified in the protocol):
AF burden and rhythm outcomes (ILR-derived): AF burden over time, recurrence patterns, and detection of clinically relevant rhythm events.
Healthcare utilisation: hospitalisations and AF/HF-related care contacts.
Patient-reported outcomes: symptom burden and HRQoL using validated instruments (including RAND-36 and additional AF-related questionnaires per protocol).
Safety outcomes: procedure-related and treatment-related complications and serious adverse events.
Treatment pathways: need for cardioversion, medication escalation, AV-node ablation with pacing, and crossover patterns (as applicable).
Exploratory Objectives and Planned Subgroup/Modifier Analyses
Exploratory analyses will examine whether treatment effects differ by baseline characteristics and geriatric domains, including:
Frailty (e.g., Frailty Index and/or Clinical Frailty Scale).
Cognitive status (protocol-defined assessment).
Inflammatory biomarkers and overall comorbidity burden.
Sex (sex-disaggregated reporting and interaction analyses).
AF type (paroxysmal vs persistent).
Imaging substudy (selected Swedish sites): a predefined subgroup (e.g., at Karolinska and Linköping) planned for brain and/or cardiac imaging with MRI and/or CT per protocol to explore mechanistic associations.
Saliva sampling (optional subgroup): in a predefined subgroup, saliva is collected for exploratory biomarker/genetic analyses relevant to ageing and treatment response (separate consent; optional participation).
If subgroup analyses are underpowered, results will be reported as exploratory.
Sample Size and Statistical Considerations
The planned sample size is 282 participants, providing adequate power to detect clinically meaningful differences over 24 months, accounting for crossover and loss to follow-up. Primary analyses are performed according to the intention-to-treat principle. Multiplicity across the two primary endpoints is addressed using a pre-specified Holm-Bonferroni approach.
Safety Oversight
Participant safety is overseen by an independent Data Monitoring Committee (DMC), comprising senior cardiology researchers independent of the study (Professor Eva Swahn, Professor Lars Lund, and Professor Johan Engdahl). Safety monitoring and adverse event reporting are conducted throughout the study according to the protocol.
Ethics, Regulatory, and Data Protection
The study has been approved by the Swedish Ethical Review Authority (Dnr 2025-02305-01; decision date 12 May 2025); amendment approved 19 May 2026 (Dnr 2026-02894-02). Data are pseudonymised and processed in compliance with GDPR, with data captured in an electronic CRF (REDCap).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated, multicenter, parallel-group randomized controlled trial with 1:1 allocation to two management strategies (catheter ablation vs optimized medical therapy). Open-label due to the nature of the interventions; follow-up through 24 months with continuous ILR monitoring in both arms.
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation Strategy | Active comparator | Procedure: Catheter Ablation for Atrial Fibrillation, Drug: Optimized Medical Therapy for Atrial Fibrillation, Device: Implantable Loop Recorder (ILR)Participants randomized to this arm will undergo catheter ablation for atrial fibrillation, with pulmonary vein isolation (PVI) prioritized as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology). Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. Additional medical therapy may be used as clinically indicated according to guideline-based care. |
| Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing | Active comparator | Drug: Optimized Medical Therapy for Atrial Fibrillation, Procedure: AV Node Ablation With Pacemaker implantationParticipants randomized to this arm will receive optimized guideline-directed medical therapy for atrial fibrillation without AF catheter ablation. Treatment may include rate control and/or rhythm control (including antiarrhythmic drugs and/or cardioversion when clinically appropriate). AV node ablation with pacemaker implantation is permitted when clinically indicated according to routine care. Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. |
Who may qualify
- Ages
- 78 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥78 years.
- ECG-documented atrial fibrillation.
- AF type: paroxysmal, persistent, or longstanding persistent AF.
- Suitable candidate for catheter ablation according to ESC guidelines.
- Charlson's comorbidity index ≤7.
Key exclusion criteria (10 listed)
- Left atrial (LA) dimension >55 mm, based on echocardiography within the previous year.
- Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.
- Severe valvular heart disease (per ESC definitions) or congenital heart disease.
- Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.
- Contraindication to oral anticoagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Ablation for Atrial FibrillationAlso: catheter ablation, pulmonary vein isolationCatheter ablation for symptomatic atrial fibrillation with pulmonary vein isolation (PVI) prioritized as the primary lesion set. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology), performed under routine standards of care at experienced centres. | Procedure or surgery | Catheter Ablation Strategy |
| Optimized Medical Therapy for Atrial FibrillationAlso: Guideline-directed medical therapy, Rate control, Rhythm controlGuideline-directed rate and/or rhythm control tailored to the participant's clinical condition, including rate-control medications and/or antiarrhythmic drugs and cardioversion when clinically appropriate. AF ablation is not performed as part of this strategy. | Drug | Catheter Ablation Strategy, Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing |
| Implantable Loop Recorder (ILR)Subcutaneous implantable loop recorder used for continuous rhythm monitoring and quantification of atrial fibrillation burden throughout follow-up. Implanted in all participants according to protocol-defined workflow. | Device | Catheter Ablation Strategy |
| AV Node Ablation With Pacemaker implantationAV node ablation with permanent pacing may be performed when clinically indicated according to routine care, as part of the optimized medical therapy strategy. | Procedure or surgery | Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing |
Primary outcome
Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization)
Time frame: 24 months after intervention (visit 2)
First part of the co-primary outcome: Proportion of participants with ≥1 of the following events within 24 months after intervention (visit 2): all-cause death, stroke, serious bleeding, cardiac arrest, or hospitalization for heart failure. Events will be adjudicated per protocol.
Change in RAND-36 General Health score
Time frame: Baseline to 24 months after intervention (visit 2)
Second part of the co-primary outcome: Change from baseline in the RAND-36 "General Health" domain score at 24 months after the intervention (visit 2). Scores range 0-100; higher scores indicate better perceived health. Intention-to-treat. Because HRQoL is undefined after death, scores are not imputed for participants who die before the 24-month assessment; instead, deceased participants are assigned the worst rank (worst-rank / composite estimand, ICH E9(R1)) and the primary comparison uses a rank-based test. Missing data other than death are handled under a missing-at-random assumption with pre-specified sensitivity analyses.
13 secondary outcomes
Differences of atrial fibrillation and atrial tachycardia burden (ILR-derived) between groups
Time frame: From date of ILR implantation (intervention day, visit 2) up to 30 months after implantation.
Hospitalizations (all-cause and cardiovascular)
Time frame: Up to 24 months after intervention
Serious adverse events and treatment-related complications
Time frame: Up to 24 months after intervention
Additional patient-reported outcomes (AF symptoms / disease-specific HRQoL)
Time frame: Baseline and follow-up (3, 12, 18) through 24 months after intervention
Changes in Left atrial reservoir strain (LASr)
Time frame: Up to 12 months after intervention (visit 2)
Cognitive function measured by Montreal Cognitive Assessment (MoCA)
Time frame: MoCA scores will be collected and assessed at baseline, 12, 18, and 24 months after intervention (visit 2).
Frailty score assessed by e-Frailty index
Time frame: Up to 24 months after intervention; visit 2 ( 12, 18, and 24 months)
Discrimination of a prediction model for the ACE-AF primary composite outcome
Time frame: From baseline up to 24 months after intervention (visit 2).
Predictors of differential treatment effect on AF/AT burden
Time frame: From implantation (visit 2) up to 30 months after intervention
Participants with at least one event in the composite neurological endpoint (dementia, stroke, intracranial hemorrhage)
Time frame: Up to 24 months after intervention (visit 2).
Total healthcare costs per participant
Time frame: Up to 24 months after intervention (visit 2)
All-cause mortality, stroke/TIA, serious bleeding, cardiac arrest, hospitalization due to heart failure analyzed separately
Time frame: Up to 24 months after intervention
Incident dementia
Time frame: Up to 24 months after intervention (visit 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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- Background: PubMed 29757320Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 38000669Jung M, Yang PS, Kim D, Sung JH, Jang E, Yu HT, Kim TH, Uhm JS, Pak HN, Lee MH, Joung B. Multimorbidity in atrial fibrillation for clinical implications using the Charlson Comorbidity Index. Int J Cardiol. 2024 Mar 1;398:131605. doi: 10.1016/j.ijcard.2023.131605. Epub 2023 Nov 22.
- Background: PubMed 34933570Bahnson TD, Giczewska A, Mark DB, Russo AM, Monahan KH, Al-Khalidi HR, Silverstein AP, Poole JE, Lee KL, Packer DL; CABANA Investigators. Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial. Circulation. 2022 Mar 15;145(11):796-804. doi: 10.1161/CIRCULATIONAHA.121.055297. Epub 2021 Dec 22.
- Background: PubMed 30874766Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results, plus a data dictionary, will be shared with researchers whose proposal is approved by the ACE-AF steering committee, under a signed data-access agreement and controlled access, in compliance with GDPR, Swedish law and the study's ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanouil Charitakis, MD, PhD principal investigator
Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation for Atrial Fibrillation, Optimized Medical Therapy for Atrial Fibrillation and Implantable Loop Recorder (ILR) in people with Atrial Fibrillation (AF) and Atrial Fibrillation Ablation, run by Karolinska University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanouil Charitakis, MD, PhD (0046767877506, emmanouil.charitakis@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization) (time frame: 24 months after intervention (visit 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424690, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.