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Search / Trial NCT06878924

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

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Persistent Af

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

About Texas Cardiac Arrhythmia Research Foundation

The Texas Cardiac Arrhythmia Research Foundation is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of cardiac arrhythmias. With a focus on innovative research and collaboration, the foundation conducts rigorous clinical studies aimed at improving patient outcomes and enhancing therapeutic strategies. By leveraging cutting-edge technology and a team of experienced professionals, the foundation strives to translate scientific findings into effective clinical practices, ultimately contributing to the broader field of cardiovascular health. Through its commitment to excellence and patient-centered care, the Texas Cardiac Arrhythmia Research Foundation plays a pivotal role in shaping the future of arrhythmia management.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported