Electroporation versus Radiofrequency Ablation Guided by 3D Imaging for Repeat Atrial Fibrillation
Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw) |
| Trial ID | NCT07141745 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wroclaw
- Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw — Wroclaw, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.