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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation (AF), Ablation Techniques, Radiofrequency Catheter Ablation, Pulsed Field Ablation

In brief

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.

Key facts

Study ID: NCT07141745
Run by: Wroclaw Medical University
People needed: 250
Starts: 2025-08-30
Expected to finish: 2028-10-01
Last updated by the study team: 2025-08-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Left ventricular ejection fraction < 30% Left atrial volume index (LAVI) > 72 mL/m² Untreated hyperthyroidism Hypertrophic cardiomyopathy Severe valvular heart disease

Where it is running

Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw — Wroclaw, Poland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.