Atrial Fibrillation (AF)REPEAT-AFNCT06988202
Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation
A study testing Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) and Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) in people with Atrial Fibrillation (AF), run by University of Rochester at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) and Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 31 Dec 2031
- 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
- Age ≥ 18 years on date of consent
- One prior PVI ablation procedure > 3 months prior for persistent AF
- Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
- Eligible for repeat ablation procedure
- Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
Who cannot join
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
- Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
- Prior surgical ablation for AF
- Contraindication to systematic anticoagulation
- LA diameter on echocardiogram > 6.0 cms
- LV ejection fraction < 35%
Show all 21Show fewer
- NYHA class III-IV congestive heart failure
- Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
- Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
- Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
- Prior valve replacement with mechanical prosthesis
- Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
- Stroke within 3 calendar months prior to consent date
- Any medical condition likely to limit survival to < 1 year
- Renal failure requiring dialysis at time of consent
- Pregnancy
- History of non-compliance to medical therapy
- Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
- Inability or unwillingness to provide informed consent
- Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
- Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Rochester Clinical Cardiovascular Research Center
Rochester, New York, 14642
About this study
Official title: Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation
Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. This study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (LA) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI), Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
- Keywords
- atrial fibrillation, irregular heart beat, posterior wall isolation, pulmonary vein isolation, ablation, REPEAT-AF
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)Procedure or surgery
A doctor inserts a thin, flexible tube (called a catheter) through a blood vessel, usually in the groin, and guides it to the heart.
Once the catheter is in place, the doctor uses pulsed field electroporation, heat (radiofrequency) or cold (cryoablation) to create small scars in the area where the pulmonary veins connect to the left atrium of the heart.
These scars block the faulty electrical signals that cause AF, helping the heart maintain a normal rhythm.
Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)Procedure or surgery
PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| Repeat PVI without LA PWI | Other | Not described Receives: Procedure: Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) |
| Repeat PVI with LA PWI | Other | Not described Receives: Procedure: Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)
The AFSS is a 19-item self-report instrument measuring atrial fibrillation burden. It includes symptom severity (7 items), frequency/duration (4 items), health care utilization (4 items), and a global well-being visual analog scale. Items are summed into a composite total burden score, ranging from 0 to 100, with higher scores indicating greater symptom burden and healthcare impact.
Measured: From Baseline to Month 12
Secondary outcomes (4)
Time to First Atrial Fibrillation Episode Lasting > 30 Seconds
A proportion of patients that experience a first recurrence of atrial fibrillation or any atrial tachyarrhythmia lasting more than 30 seconds after repeat ablation (randomization), detected via monitoring.
Measured: Up to 24 Months Following Randomization
Mean Total Atrial Fibrillation Burden from Serial Holter Recordings
Total cumulative duration (in minutes or hours) of atrial fibrillation or other atrial tachyarrhythmias recorded via serial Holter monitoring during the follow-up period.
Measured: From Randomization through Month 24
Mean Total Number of Cardiovascular Health Care Utilization Events
Total number of cardiovascular-related hospital admissions, emergency room visits, and unplanned clinic visits, as recorded in medical records.
Measured: From Randomization through Month 48
Mean Total Number of Major Clinical Events
The number of adjudicated major clinical events including decompensated heart failure requiring IV therapy, myocardial infarction, stroke/TIA, major bleeding, syncope, cardiac arrest, device implantation, repeat ablation, thromboembolic events, and serious procedural complications (e.g., atrio-esophageal fistula, tamponade).
Measured: From Randomization through Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start18 Mar 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jonathan Steinberg, University of Rochester
- Investigators
- Johnathan Steinberg, MD, Principal investigator, University of RochesterWojciech Zareba, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988202
- Sponsor's protocol ID
- STUDY00010537
- Acronym
- REPEAT-AF
- Status last verified
- Mar 2026
- First submitted
- 15 May 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06988202
- Acronym / sponsor ID
- REPEAT-AF / STUDY00010537
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, irregular heart beat, posterior wall isolation, pulmonary vein isolation, ablation, REPEAT-AF
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 23 May 2025 (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.
Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. This study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (LA) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeat PVI without LA PWI | Other | Procedure: Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) |
| Repeat PVI with LA PWI | Other | Procedure: Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years on date of consent
- One prior PVI ablation procedure > 3 months prior for persistent AF
- Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
- Eligible for repeat ablation procedure
- Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
Key exclusion criteria (21 listed)
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
- Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
- Prior surgical ablation for AF
- Contraindication to systematic anticoagulation
- LA diameter on echocardiogram > 6.0 cms
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 |
|---|---|---|
| Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)A doctor inserts a thin, flexible tube (called a catheter) through a blood vessel, usually in the groin, and guides it to the heart. Once the catheter is in place, the doctor uses pulsed field electroporation, heat (radiofrequency) or cold (cryoablation) to create small scars in the area where the pulmonary veins connect to the left atrium of the heart. These scars block the faulty electrical signals that cause AF, helping the heart maintain a normal rhythm. | Procedure or surgery | Repeat PVI without LA PWI |
| Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium. | Procedure or surgery | Repeat PVI with LA PWI |
Primary outcome
Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)
Time frame: From Baseline to Month 12
The AFSS is a 19-item self-report instrument measuring atrial fibrillation burden. It includes symptom severity (7 items), frequency/duration (4 items), health care utilization (4 items), and a global well-being visual analog scale. Items are summed into a composite total burden score, ranging from 0 to 100, with higher scores indicating greater symptom burden and healthcare impact.
4 secondary outcomes
Time to First Atrial Fibrillation Episode Lasting > 30 Seconds
Time frame: Up to 24 Months Following Randomization
Mean Total Atrial Fibrillation Burden from Serial Holter Recordings
Time frame: From Randomization through Month 24
Mean Total Number of Cardiovascular Health Care Utilization Events
Time frame: From Randomization through Month 48
Mean Total Number of Major Clinical Events
Time frame: From Randomization through Month 48
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 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Johnathan Steinberg, MD principal investigator
University of Rochester
Wojciech Zareba, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) and Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) in people with Atrial Fibrillation (AF), run by University of Rochester at 1 site in United States.
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 21 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: enrolling by invitation, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS) (time frame: From Baseline to Month 12). 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 23 Mar 2026.