Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation

Launched by TEXAS CARDIAC ARRHYTHMIA RESEARCH FOUNDATION · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of treatment for patients with a type of irregular heartbeat called persistent atrial fibrillation (AF). The trial aims to compare the safety and effectiveness of two approaches: one that combines pulsed-field ablation (PFA) with isolation of a part of the heart called the posterior wall, and another that uses PFA along with alcohol treatment in a specific area of the heart called the Vein of Marshall. Both methods are designed to help restore a normal heartbeat and reduce the symptoms of AF.

To participate in this trial, individuals must be between 18 and 85 years old and have symptoms of persistent AF. They should also have had a previous procedure that focused only on pulmonary vein isolation (PVI). However, certain conditions, such as severe heart problems or recent heart surgery, may exclude someone from joining. Participants can expect to receive either of the treatments being studied and will be monitored closely throughout the trial to ensure their safety and to assess how well the treatments work. This study is not yet recruiting participants, but it represents an important step in finding effective treatments for those living with atrial fibrillation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptomatic persistent AF; 1st or redo ablation with PVI-only in the earlier procedure
• • Willing to provide informed consent
• • Age: 18-85 years
• Exclusion Criteria:
• • • Previous PWI or VoM ablation procedure
• • Left ventricular ejection fraction \<40%
• • Left atrial thrombus
• • Myocardial infarction within last 60 days
• • Cardiac surgery in the last 6 months
• • Advanced renal failure
• • Life expectancy \<1 year
• • Pregnant women
• • Unable or unwilling to provide informed consent