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 type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw) |
| Status | Recruiting |
| Started | August 30, 2025 |
| Main results expected | August 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | August 27, 2025 |
| Trial ID | NCT07141745 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
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Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw
Wroclaw, Poland Recruiting
Similar studies
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In patients with atrial fibrillation who need both ablation and left atrial appendage closure, this study tests doing both procedures in a single intervention using FARAPULSE PFA and a WATCHMAN FLX device.
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This test will see if the FARAWAVE Nav catheter's built-in mapping can be used instead of pre-procedure CT scans for adults having pulmonary vein isolation for atrial fibrillation.
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Pulsed Field vs Cryoballoon for Pulmonary Vein Isolation in Atrial Fibrillation
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.