Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07141745 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation

Study acronym: ERA-rePVI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date: Aug 15, 2025 to Aug 30, 2025v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, randomized clinical trial evaluating the efficacy and safety of two techniques for repeat catheter ablation in patients with recurrent atrial fibrillation (AF): thermal energy ablation (radiofrequency) and non-thermal electroporation (pulsed field ablation), both guided by 3D imaging systems. Patients undergoing repeat AF ablation will be randomly assigned to receive either thermal or electroporation ablation, performed according to standard hospital protocols. No additional invasive procedures are required. Following the ablation, participants will attend follow-up visits at 3, 6, and 12 months, including medical history review, physical examination, 12-lead ECG, and 24-hour Holter monitoring. Unscheduled ECG assessments will also be available if arrhythmia symptoms occur. All study-related procedures are non-invasive and align with routine post-ablation care. Risks are limited to those typically associated with standard AF ablation procedures. The main benefit of participation is close, structured follow-up by experienced electrophysiologists, allowing for early detection of arrhythmia recurrence and timely medical intervention when necessary. Participant confidentiality and data protection will be ensured in accordance with GDPR regulations.
Trial Details
NCT Number NCT07141745
Lead Sponsor Wroclaw Medical University
Conditions
(from sponsor)
Atrial Fibrillation (AF), Ablation Techniques, Radiofrequency Catheter Ablation, Pulsed Field Ablation
Related terms Atrial Fibrillation
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov