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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Documented recurrence of AF or atypical atrial flutter after prior PVI Eligibility for re-PVI

Locations
Other Locations
Poland
Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw
RECRUITING
Wroclaw
Time Frame
Start Date: 2025-08-30
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 250
Treatments
Active_comparator: PFA group
Patients in this arm will undergo 3D-mpping guided re-ablation with the PFA catheter
Active_comparator: RFA group
Patients in this arm will undergo 3D-mpping guided re-ablation with RFA catheter
Related Therapeutic Areas
Sponsors
Leads: Wroclaw Medical University

This content was sourced from clinicaltrials.gov