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

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06878924
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief Summary

This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-05
• Primary Completion: 2027-05
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial arrhythmia: any episode of AF/AT longer than 30 sec off-AAD, after the 2-month blanking period	1 year

Secondary Outcome Measures

Name	Time	Method
• Arrhythmia-free on previously ineffective AAD without any dose-escalation	1 year