Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

NCT06988202 | Enrolling By Invitation DMC

• 1 other identifier: STUDY00010537
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

atrial fibrillation; irregular heart beat; posterior wall isolation; pulmonary vein isolation; ablation; REPEAT-AF

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Month 12

Secondary Outcomes (4)

• Time to First Atrial Fibrillation Episode Lasting > 30 Seconds

  Up to 24 Months Following Randomization

• Mean Total Atrial Fibrillation Burden from Serial Holter Recordings

  From Randomization through Month 24

• Mean Total Number of Cardiovascular Health Care Utilization Events

  From Randomization through Month 48

• Mean Total Number of Major Clinical Events

  From Randomization through Month 48

Study Arms (2)

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)

Interventions

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.

Repeat PVI without LA PWI

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.

Repeat PVI with LA PWI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Rochester Clinical Cardiovascular Research Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnathan Steinberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Wojciech Zareba, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Medicine

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)