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Enrolling by Invitation

NCT Number: NCT06988202

Comparative Effectiveness of Different Techniques for Repeat Ablation of 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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Clinical Cardiovascular Research Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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%
  • 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

Treatment and study plan

Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)

Procedure

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

PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to First Atrial Fibrillation Episode Lasting > 30 Seconds

    Time frame: Up to 24 Months Following Randomization

    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.

  2. Mean Total Atrial Fibrillation Burden from Serial Holter Recordings

    Time frame: From Randomization through Month 24

    Total cumulative duration (in minutes or hours) of atrial fibrillation or other atrial tachyarrhythmias recorded via serial Holter monitoring during the follow-up period.

  3. Mean Total Number of Cardiovascular Health Care Utilization Events

    Time frame: From Randomization through Month 48

    Total number of cardiovascular-related hospital admissions, emergency room visits, and unplanned clinic visits, as recorded in medical records.

  4. Mean Total Number of Major Clinical Events

    Time frame: From Randomization through Month 48

    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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation

Acronym: REPEAT-AF

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
May 23, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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