Clinical trial Recruiting at 1 site Interventional Ages 18 to 85

Electroporation versus Radiofrequency Ablation Guided by 3D Imaging for Repeat Atrial Fibrillation

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

Run by Wroclaw Medical University · NCT07141745 · Data updated 2026-11-12

This trial tests whether pulsed field electroporation or standard radiofrequency ablation works better and safer for people having a repeat catheter ablation for recurrent atrial fibrillation.

Quick facts

Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment250 (estimated)
SponsorWroclaw Medical University
Academic / other
Locations1 site (Wroclaw)
StatusRecruiting
StartedAugust 30, 2025
Main results expectedAugust 1, 2028
Study endsOctober 1, 2028
Registry record updatedAugust 27, 2025
Trial IDNCT07141745 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with documented recurrent atrial fibrillation or atypical atrial flutter after prior pulmonary vein isolation who are eligible for repeat PVI and meet the study's cardiac function and anatomy criteria.

Probably not a fit

Patients with severely reduced left ventricular function (LVEF < 30%), very large left atria (LAVI > 72 mL/m²), untreated hyperthyroidism, hypertrophic cardiomyopathy, or severe valvular disease are excluded and unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized trial assigns patients with recurrent AF who need repeat pulmonary vein isolation to receive either non-thermal pulsed field electroporation or standard radiofrequency ablation, both performed with 3D electroanatomical mapping. Procedures follow routine hospital protocols and require no additional invasive tests beyond the re-ablation. Participants return for clinical review, 12-lead ECG and 24-hour Holter monitoring at 3, 6, and 12 months, with unscheduled ECGs available if symptoms recur. The study compares procedural safety, arrhythmia recurrence, and need for further interventions between the two approaches.

Why it matters

Potential benefit: If successful, this could show that electroporation reduces complications or recurrence compared with radiofrequency in repeat AF ablation, improving outcomes after re-PVI.

How similar studies have gone: Randomized and registry data for initial PVI suggest pulsed field ablation has comparable efficacy and possibly improved safety versus thermal methods, but no prior prospective randomized trial has tested PFA specifically in repeat ablation procedures.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

  • Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw
    Wroclaw, Poland
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.