Atrial FibrillationNCT06324188
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
A study testing Early atrial fibrillation ablation in people with Atrial Fibrillation, run by Atrial Fibrillation Network at 7 sites in 7 countries.
Trial summary
EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial). The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Early atrial fibrillation ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,312 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 14 Oct 2024to May 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I1. AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG
- I2. High comorbidity estimated by CHA2DS2-VASc score of 4 or more
- I3. Patient suitable for ablation using cryoballoon ablation systems or other ablation systems with comparable efficacy and safety from Medtronic
- I4. Age ≥ 18 years
- I5. Provision of signed informed consent
Who cannot join
- General exclusion criteria
- E1. Any disease that limits life expectancy to less than 1 year.
- E2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).
- E3. Previous participation in EASThigh-AFNET 11.
- E4. Pregnant women.
- E5. Breastfeeding women.
Show all 12Show fewer
- E6. Drug abuse or clinically manifest alcohol abuse.
- E7. Prior AF ablation or surgical therapy of AF.
- E8. Patients not suitable for AF ablation.
- E9. Patients with a history of stroke which occurred within 3 months prior to enrolment.
- E10. Valve disease requiring specific therapy.
- E11. Clinically manifested thyroid dysfunction requiring therapy.
Trial locations and contacts
7 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 7 countries
Australia1 site, 1 recruiting
- Not yet recruiting
Several sites
Multiple Locations
Netherlands1 site, 1 recruiting
- Recruiting
Several sites
Multiple Locations
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Several sites
Multiple Locations
About this study
EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).
The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.
Read the detailed description
Atrial Fibrillation (AF) is associated with high morbidity and mortality. Even on optimal anticoagulation and therapy of concomitant conditions, many patients with AF suffer cardiovascular events, especially heart failure events, stroke, and cardiovascular death. Most of these events occur in elderly patients with comorbidities. Early rhythm control, mainly delivered using antiarrhythmic drugs, reduces AF-related complications when added to anticoagulation, rate control, and treatment of comorbidities when compared to current practice that offers rhythm control mainly to reduce symptoms. The outcome-reducing effect of early rhythm control is most pronounced in patients with multiple comorbidities, quantified by a CHA2DS2-VASc score ≥ 4. Attaining sinus rhythm is the key mediator for the outcome-reducing effect of early rhythm control. Atrial fibrillation ablation controls the rhythm better than drug-based rhythm control, avoids long-term antiarrhythmic drug treatment, thus reducing polypharmacy, and may therefore be the ideal rhythm control treatment in patients with AF and a high comorbidity burden. This hypothesis needs testing. The investigator-initiated EASThigh-AFNET 11 trial evaluates the effectiveness and safety of early atrial fibrillation ablation in patients with recently diagnosed AF and a high comorbidity burden.
EASThigh-AFNET 11 is a Treatment Strategy trial randomizing 2312 patients with AF and a high comorbidity burden to early atrial fibrillation ablation or usual care to achieve a fixed number of primary endpoint events of n=527. All therapies are clinically approved. The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for worsening of heart failure. The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. Secondary outcome parameters address safety, patient reported outcomes and cognitive function.
EASThigh-AFNET 11 was recommended for funding by the Expert Advisory Panel of the Global Cardiovascular Research Funders Forum (GCRFF).
- Conditions
- Atrial Fibrillation
- Being tested
- Early atrial fibrillation ablation, Usual Care
- Keywords
- Early atrial fibrillation ablation, High comorbidity burden, CHA2DS2-VASc score, Early rhythm control, Stroke, Heart failure, Cardiovascular death, Cryoballoon
- Medical subject headings
- Atrial Fibrillation, Stroke, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early atrial fibrillation ablationOther
Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.
Usual CareOther
Usual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.
| Study group | Role | What they receive |
|---|---|---|
| Early atrial fibrillation ablation | Other | Not described Receives: Other: Early atrial fibrillation ablation |
| Usual Care | Other | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiovascular complications related to AF
It is defined as time from randomisation to the first occurrence of a composite of cardiovascular death, stroke (either ischemic or hemorrhagic), or hospitalisation for worsening of heart failure.
Measured: Throughout study completion, estimated at a mean of 4 years
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter.
Measured: Throughout study completion, estimated at a mean of 4 years
Secondary outcomes (14)
Number of nights spent in hospital
Measured: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first occurrence of each of the individual components of the primary outcome
Measured: Throughout study completion, estimated at a mean of 4 years
All-cause death
Measured: Throughout study completion, estimated at a mean of 4 years
Serious adverse events related to AF therapy
Measured: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first cardiovascular hospitalisation
Measured: Throughout study completion, estimated at a mean of 4 years
Number of cardiovascular hospitalisations (over-night stay)
Measured: Throughout study completion, estimated at a mean of 4 years
Changes in left ventricular ejection fraction
Measured: comparing baseline with 24 months follow up (FU)
Changes in quality of life
assessed by EQ-5D-5L
Measured: comparing baseline with 12 and 24 months FU
Changes in quality of life
assessed by AFEQT
Measured: comparing baseline with 12 and 24 months FU
Changes in cognitive function
assessed by Montreal-Cognitive-Assessment-Test
Measured: comparing baseline with 24 months FU
Cardiac rhythm status
sinus rhythm compared to AF
Measured: at 12 and 24 months FU
AF pattern
Measured: at 12 and 24 months FU
Time from randomisation to first clinical recurrence of AF
Measured: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first progression of AF
- e. from paroxysmal to persistent or longstanding persistent or permanent and each of these components
Measured: Throughout study completion, estimated at a mean of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start14 Oct 2024
- Primary completionFeb 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulus Kirchhof, Prof. Dr., Study director, University Heart and Vascular Center Hamburg, University Hospital Hamburg EppendorfAndreas Rillig, PD Dr., Study director, University Heart and Vascular Center Hamburg, University Hospital Hamburg EppendorfJason Andrade, Prof. Dr., Principal investigator, University of British Columbia, Vancouver General Hospital, Department of ElectrophysiologyAndré Ng, Prof. Dr., Principal investigator, Department of Cardiovascular Sciences, University of LeicesterPrash Sanders, Prof. Dr., Principal investigator, Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide HospitalVolker Straub, Principal investigator, Patient representativeKevin Vernooy, Prof. Dr., Principal investigator, Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)Antonia Zapf, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324188
- Sponsor's protocol ID
- EASThigh-AFNET 11
- Status last verified
- Nov 2025
- First submitted
- 4 Mar 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
PubMed 32865375Rillig A, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Goette A, Kuck KH, Metzner A, Vardas P, Vettorazzi E, Wegscheider K, Zapf A, Kirchhof P. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation. 2022 Sep 13;146(11):836-847. doi: 10.1161/CIRCULATIONAHA.122.060274. Epub 2022 Aug 15.
PubMed 35968706Eckardt L, Sehner S, Suling A, Borof K, Breithardt G, Crijns H, Goette A, Wegscheider K, Zapf A, Camm J, Metzner A, Kirchhof P. Attaining sinus rhythm mediates improved outcome with early rhythm control therapy of atrial fibrillation: the EAST-AFNET 4 trial. Eur Heart J. 2022 Oct 21;43(40):4127-4144. doi: 10.1093/eurheartj/ehac471.
PubMed 36036648Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
PubMed 33197159Andrade JG, Deyell MW, Macle L, Wells GA, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Cadrin-Tourigny J, Kochhauser S, Verma A; EARLY-AF Investigators. Progression of Atrial Fibrillation after Cryoablation or Drug Therapy. N Engl J Med. 2023 Jan 12;388(2):105-116. doi: 10.1056/NEJMoa2212540. Epub 2022 Nov 7.
PubMed 36342178Dickow J, Kirchhof P, Van Houten HK, Sangaralingham LR, Dinshaw LHW, Friedman PA, Packer DL, Noseworthy PA, Yao X. Generalizability of the EAST-AFNET 4 Trial: Assessing Outcomes of Early Rhythm-Control Therapy in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jun 7;11(11):e024214. doi: 10.1161/JAHA.121.024214. Epub 2022 May 27.
PubMed 35621202Dickow J, Kany S, Roth Cardoso V, Ellinor PT, Gkoutos GV, Van Houten HK, Kirchhof P, Metzner A, Noseworthy PA, Yao X, Rillig A. Outcomes of Early Rhythm Control Therapy in Patients With Atrial Fibrillation and a High Comorbidity Burden in Large Real-World Cohorts. Circ Arrhythm Electrophysiol. 2023 May;16(5):e011585. doi: 10.1161/CIRCEP.122.011585. Epub 2023 Mar 21.
PubMed 36942567
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
- ClinicalTrials.gov ID
- NCT06324188
- Acronym / sponsor ID
- EASThigh-AFNET 11
- Conditions
- Atrial Fibrillation
- Keywords
- Early atrial fibrillation ablation, High comorbidity burden, CHA2DS2-VASc score, Early rhythm control, Stroke, Heart failure, Cardiovascular death, Cryoballoon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,312 participants (estimated)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 21 Mar 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.
EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).
The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.
Detailed description
Atrial Fibrillation (AF) is associated with high morbidity and mortality. Even on optimal anticoagulation and therapy of concomitant conditions, many patients with AF suffer cardiovascular events, especially heart failure events, stroke, and cardiovascular death. Most of these events occur in elderly patients with comorbidities. Early rhythm control, mainly delivered using antiarrhythmic drugs, reduces AF-related complications when added to anticoagulation, rate control, and treatment of comorbidities when compared to current practice that offers rhythm control mainly to reduce symptoms. The outcome-reducing effect of early rhythm control is most pronounced in patients with multiple comorbidities, quantified by a CHA2DS2-VASc score ≥ 4. Attaining sinus rhythm is the key mediator for the outcome-reducing effect of early rhythm control. Atrial fibrillation ablation controls the rhythm better than drug-based rhythm control, avoids long-term antiarrhythmic drug treatment, thus reducing polypharmacy, and may therefore be the ideal rhythm control treatment in patients with AF and a high comorbidity burden. This hypothesis needs testing. The investigator-initiated EASThigh-AFNET 11 trial evaluates the effectiveness and safety of early atrial fibrillation ablation in patients with recently diagnosed AF and a high comorbidity burden.
EASThigh-AFNET 11 is a Treatment Strategy trial randomizing 2312 patients with AF and a high comorbidity burden to early atrial fibrillation ablation or usual care to achieve a fixed number of primary endpoint events of n=527. All therapies are clinically approved. The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for worsening of heart failure. The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. Secondary outcome parameters address safety, patient reported outcomes and cognitive function.
EASThigh-AFNET 11 was recommended for funding by the Expert Advisory Panel of the Global Cardiovascular Research Funders Forum (GCRFF).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early atrial fibrillation ablation | Other | Other: Early atrial fibrillation ablation |
| Usual Care | Other | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- I1. AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG
- I2. High comorbidity estimated by CHA2DS2-VASc score of 4 or more
- I3. Patient suitable for ablation using cryoballoon ablation systems or other ablation systems with comparable efficacy and safety from Medtronic
- I4. Age ≥ 18 years
- I5. Provision of signed informed consent
Key exclusion criteria (12 listed)
- General exclusion criteria
- E1. Any disease that limits life expectancy to less than 1 year.
- E2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).
- E3. Previous participation in EASThigh-AFNET 11.
- E4. Pregnant women.
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 |
|---|---|---|
| Early atrial fibrillation ablationPatients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation. | Other | Early atrial fibrillation ablation |
| Usual CareUsual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient. | Other | Usual Care |
Primary outcome
Composite of cardiovascular complications related to AF
Time frame: Throughout study completion, estimated at a mean of 4 years
It is defined as time from randomisation to the first occurrence of a composite of cardiovascular death, stroke (either ischemic or hemorrhagic), or hospitalisation for worsening of heart failure.
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
Time frame: Throughout study completion, estimated at a mean of 4 years
Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter.
14 secondary outcomes
Number of nights spent in hospital
Time frame: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first occurrence of each of the individual components of the primary outcome
Time frame: Throughout study completion, estimated at a mean of 4 years
All-cause death
Time frame: Throughout study completion, estimated at a mean of 4 years
Serious adverse events related to AF therapy
Time frame: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first cardiovascular hospitalisation
Time frame: Throughout study completion, estimated at a mean of 4 years
Number of cardiovascular hospitalisations (over-night stay)
Time frame: Throughout study completion, estimated at a mean of 4 years
Changes in left ventricular ejection fraction
Time frame: comparing baseline with 24 months follow up (FU)
Changes in quality of life
Time frame: comparing baseline with 12 and 24 months FU
Changes in quality of life
Time frame: comparing baseline with 12 and 24 months FU
Changes in cognitive function
Time frame: comparing baseline with 24 months FU
Cardiac rhythm status
Time frame: at 12 and 24 months FU
AF pattern
Time frame: at 12 and 24 months FU
Time from randomisation to first clinical recurrence of AF
Time frame: Throughout study completion, estimated at a mean of 4 years
Time from randomisation to first progression of AF
Time frame: Throughout study completion, estimated at a mean of 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 8 Jan 2026.
- Background: PubMed 32865375Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
- Background: PubMed 35968706Rillig A, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Goette A, Kuck KH, Metzner A, Vardas P, Vettorazzi E, Wegscheider K, Zapf A, Kirchhof P. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation. 2022 Sep 13;146(11):836-847. doi: 10.1161/CIRCULATIONAHA.122.060274. Epub 2022 Aug 15.
- Background: PubMed 36036648Eckardt L, Sehner S, Suling A, Borof K, Breithardt G, Crijns H, Goette A, Wegscheider K, Zapf A, Camm J, Metzner A, Kirchhof P. Attaining sinus rhythm mediates improved outcome with early rhythm control therapy of atrial fibrillation: the EAST-AFNET 4 trial. Eur Heart J. 2022 Oct 21;43(40):4127-4144. doi: 10.1093/eurheartj/ehac471.
- Background: PubMed 33197159Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
- Background: PubMed 36342178Andrade JG, Deyell MW, Macle L, Wells GA, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Cadrin-Tourigny J, Kochhauser S, Verma A; EARLY-AF Investigators. Progression of Atrial Fibrillation after Cryoablation or Drug Therapy. N Engl J Med. 2023 Jan 12;388(2):105-116. doi: 10.1056/NEJMoa2212540. Epub 2022 Nov 7.
- Background: PubMed 35621202Dickow J, Kirchhof P, Van Houten HK, Sangaralingham LR, Dinshaw LHW, Friedman PA, Packer DL, Noseworthy PA, Yao X. Generalizability of the EAST-AFNET 4 Trial: Assessing Outcomes of Early Rhythm-Control Therapy in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jun 7;11(11):e024214. doi: 10.1161/JAHA.121.024214. Epub 2022 May 27.
- Background: PubMed 36942567Dickow J, Kany S, Roth Cardoso V, Ellinor PT, Gkoutos GV, Van Houten HK, Kirchhof P, Metzner A, Noseworthy PA, Yao X, Rillig A. Outcomes of Early Rhythm Control Therapy in Patients With Atrial Fibrillation and a High Comorbidity Burden in Large Real-World Cohorts. Circ Arrhythm Electrophysiol. 2023 May;16(5):e011585. doi: 10.1161/CIRCEP.122.011585. Epub 2023 Mar 21.
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Atrial Fibrillation (AF)
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.
Paulus Kirchhof, Prof. Dr. study director
University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf
Andreas Rillig, PD Dr. study director
University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf
Jason Andrade, Prof. Dr. principal investigator
University of British Columbia, Vancouver General Hospital, Department of Electrophysiology
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early atrial fibrillation ablation in people with Atrial Fibrillation, run by Atrial Fibrillation Network at 7 sites in 7 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 5 inclusion and 12 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Canada, Germany, Netherlands, Poland and 2 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 Antje Albring, Dr. (+49 251 980 1330, easthigh@af-net.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular complications related to AF (time frame: Throughout study completion, estimated at a mean of 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?
On the ClinicalTrials.gov record for NCT06324188, which also lists 7 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 Jan 2026.