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ENROLLING BY INVITATION

NCT06988202

Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

Sponsor: University of Rochester

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

630

Start Date

2026-03-18

Completion Date

2031-12-31

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)

Interventions

PROCEDURE

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

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.

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

Locations (1)

University of Rochester Clinical Cardiovascular Research Center

Rochester, New York, United States