Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation (REPEAT-AF)

University of Rochester

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI); Procedure: Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06988202

STUDY00010537

Details and patient eligibility

About

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.

Enrollment: 630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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630 participants in 2 patient groups

Repeat PVI without LA PWI

Other group

Treatment:

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

Repeat PVI with LA PWI

Other group

Treatment:

Procedure: Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)