Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

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.

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