Atrial Fibrillation, PersistentABACUSNCT06207383
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
A study testing Conduction system pacing, Atrioventricular nodal ablation and Atrial fibrillation ablation in people with Atrial Fibrillation, Persistent and Heart Failure, run by University Hospital, Geneva at 18 sites in 14 countries.
Trial summary
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent, Heart Failure
- What is being tested?
- Conduction system pacing, Atrioventricular nodal ablation and Atrial fibrillation ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 18 sitesin 14 countries
- Study dates
- 1 Oct 2024to Dec 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.
- At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP > 1000 pg/ml or BNP > 250 pg/ml measured at any timepoint during this interval.
- Previous or current rate or rhythm control drug therapy. (iv) Age > 60 years
Who cannot join
- NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.
- Life expectancy < 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.
- Participation in another controlled trial. (vii) Inability to sign and informed consent form.
Trial locations and contacts
18 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 14 countries
Switzerland4 sites, 4 recruiting
- Recruiting
University Hospital of Basel
Basel
Philipp Krisai, +41 61 265 25 25, philipp.krisai@usb.ch
- Recruiting
Inselspital
Bern
Nikola Kozhuharov, +41 31 632 21 11, nikola.kozhuharov@googlemail.com
- Recruiting
University Hospital Geneva
Geneva, Canton of Geneva, 1211
Haran Burri, Prof., +41 (0)22 309 45 45, Haran.Burri@Hcuge.ch
- Recruiting
University Hospital of Zurich
Zurich
Alexander Breitenstein, +41 44 25 59 77, Alexander.Breitenstein@usz.ch
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitario La Paz
Madrid
Jose Merino, +34-619974115, jlmerino@arritmias.net
- Not yet recruiting
Hospital Universitario y Politecnico La Fe
Madrid
Oscar Cano, +34 961 24 40 00, oscape13@hotmail.com
Austria1 site, 1 recruiting
- Not yet recruiting
St Elisabeth sister's Hospital
Graz
Helmut Puerfellner, +43-732-7676-0, Helmut.Puererfellner@ordensklinikum.at
Belgium1 site, 1 recruiting
- Not yet recruiting
Antwerp University Hospital
Antwerp
Hein Heidbuchel, +32 495 26 56 11, hein.heidbuchel@uza.be
Bulgaria1 site, 1 recruiting
- Not yet recruiting
Acibadem City Clinic Tokuda University Hospital
Sofia
Vassil Traykov, +35924034606, Vasil.TRAYKOV@acibademcityclinic.bg
Czechia1 site, 1 recruiting
- Not yet recruiting
University Hospital, Kralovske Vinohrady
Prague
Karol Curila, 00420777869171, curilakarol@seznam.cz
Finland1 site, 1 recruiting
- Recruiting
Heart and Lung Center, University of Helsinki
Helsinki
Jaarko Karvonen, +358 50 428 6728, jarkko.karvonen@hus.fi
France1 site, 1 recruiting
- Not yet recruiting
Hôpital Charles Nicolle
Rouen
Fréderic Anselme, +33 232888111, Frederic.anselme@chu-rouen.fr
Germany1 site, 1 recruiting
- Not yet recruiting
Herzzentrum Leipzig
Leipzig
Kerstin Bode, 034 865-1476, Kerstin.Bode@helios-gesundheit.de
Kerstin.Bode@helios-gesundheit.de
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University
Budapest
Laszlo Geller, +36208258019, laszlo.geller@gmail.com
Italy1 site, 1 recruiting
- Not yet recruiting
Bologna University Hospital
Bologna
Mauro Biffi, +39(0)512143867, mauro.biffi@aosp.bo.it
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Hospital Maastricht
Maastricht
Kevin Vernooy, +31 43 387 6543, kevin.vernooy@mumc.nl
Poland1 site, 1 recruiting
- Not yet recruiting
Jagiellonian University
Krakow
Marek Jastrzebski, +48 502 545 228, mcjastrz@cyf-kr.edu.pl
United Kingdom1 site, 1 recruiting
- Not yet recruiting
National Heart and Lung Institute, Imperial College London
London
Zachary Whinnett, +44 20 7594 8161, z.whinnett@imperial.ac.uk
About this study
Official title: Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.
Read the detailed description
Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients.
Hypotheses
- CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization.
- CSP+AVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization.
Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in ~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation.
Sample size 220 patients
Study duration 4 years
- Conditions
- Atrial Fibrillation, Persistent, Heart Failure
- Being tested
- Conduction system pacing, Atrioventricular nodal ablation, Atrial fibrillation ablation
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conduction system pacingDevice
Conduction system pacing (either His bundle pacing or left bundle branch area pacing)
Atrioventricular nodal ablationProcedure or surgery
Catheter ablation of the atrioventricular node
Atrial fibrillation ablationProcedure or surgery
Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation ablation | Other | Catheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint. Receives: Procedure: Atrial fibrillation ablation |
| Conduction system pacing + atrioventricular nodal ablation | Active comparator | Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node. Receives: Device: Conduction system pacing; Procedure: Atrioventricular nodal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority endpoint
Incidence of mortality and cardiovascular hospitalization in each arm
Measured: 1-4 years
Non-inferiority endpoint
Incidence of mortality and heart failure hospitalization in each arm
Measured: 1-4 years
Secondary outcomes (5)
Minnesota Living with Heart Failure quality of life measure
The questionnaire is comprised of 21 questions around physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0-5 scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is scored by summation of all 21 responses (the higher the score, the worse the quality of life).
Measured: 1 year
Left ventricular ejection fraction
Measurement using echocardiography
Measured: 1 year
Complications
Peri-procedural and long-term
Measured: 1-4 years
NYHA class
New York Heart Association classification of heart failure symptoms
Measured: 1-4 years
Cost-Effectiveness Analysis
Evaluation of clinical outcomes and associated costs between between the study arms. This evaluation will be conducted from a societal perspective, capturing both the direct medical costs and the broader societal impacts of the interventions.
Measured: 1-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Haran Burri, MD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207383
- Sponsor's protocol ID
- SNF_32003B_220116
- Acronym
- ABACUS
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data repository
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
- ClinicalTrials.gov ID
- NCT06207383
- Acronym / sponsor ID
- ABACUS / SNF_32003B_220116
- Conditions
- Atrial Fibrillation, Persistent, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jan 2024 (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.
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.
Detailed description
Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients.
Hypotheses
- CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization.
- CSP+AVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization.
Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in ~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation.
Sample size 220 patients
Study duration 4 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation ablation | Other | Procedure: Atrial fibrillation ablationCatheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint. |
| Conduction system pacing + atrioventricular nodal ablation | Active comparator | Device: Conduction system pacing, Procedure: Atrioventricular nodal ablationConduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.
- At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP > 1000 pg/ml or BNP > 250 pg/ml measured at any timepoint during this interval.
- Previous or current rate or rhythm control drug therapy. (iv) Age > 60 years
Key exclusion criteria (3 listed)
- NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.
- Life expectancy < 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.
- Participation in another controlled trial. (vii) Inability to sign and informed consent form.
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 |
|---|---|---|
| Conduction system pacingConduction system pacing (either His bundle pacing or left bundle branch area pacing) | Device | Conduction system pacing + atrioventricular nodal ablation |
| Atrioventricular nodal ablationCatheter ablation of the atrioventricular node | Procedure or surgery | Conduction system pacing + atrioventricular nodal ablation |
| Atrial fibrillation ablationCatheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary) | Procedure or surgery | Atrial fibrillation ablation |
Primary outcome
Superiority endpoint
Time frame: 1-4 years
Incidence of mortality and cardiovascular hospitalization in each arm
Non-inferiority endpoint
Time frame: 1-4 years
Incidence of mortality and heart failure hospitalization in each arm
5 secondary outcomes
Minnesota Living with Heart Failure quality of life measure
Time frame: 1 year
Left ventricular ejection fraction
Time frame: 1 year
Complications
Time frame: 1-4 years
NYHA class
Time frame: 1-4 years
Cost-Effectiveness Analysis
Time frame: 1-4 years
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 6 Dec 2024.
- Individual participant dataSharing planned: Yes. Data repository
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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.
18 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conduction system pacing, Atrioventricular nodal ablation and Atrial fibrillation ablation in people with Atrial Fibrillation, Persistent and Heart Failure, run by University Hospital, Geneva at 18 sites in 14 countries.
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 3 inclusion and 3 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Switzerland, Spain, Austria, Belgium, Bulgaria and 9 more countries. 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 Haran Burri (+41794616217, haran.burri@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority endpoint (time frame: 1-4 years). 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?
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 6 Dec 2024.