RecruitingNot ApplicableNCT07141745

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


Sponsor

Wroclaw Medical University

Enrollment

250 participants

Start Date

Aug 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two procedures used to treat atrial fibrillation (irregular heartbeat) that has come back after an earlier procedure: electroporation (a newer technology using electrical pulses) versus radiofrequency ablation (using heat). Imaging guidance will be used during both procedures. **You may be eligible if...** - You have been diagnosed with recurring atrial fibrillation or an irregular heart rhythm called atypical atrial flutter after a prior ablation procedure - You are suitable for a repeat ablation procedure **You may NOT be eligible if...** - Your heart's pumping ability (ejection fraction) is severely reduced (below 30%) - Your left atrium is significantly enlarged - You have untreated overactive thyroid - You have a thickened heart muscle condition (hypertrophic cardiomyopathy) - You have severe heart valve disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPulsed field ablation of reccurent atrial arrythmia

Substrate modification strategy based ablation of reccurent atrial arrythmia following pulmonary viens isolation employing pulsed field ablation with 3D guidance and high density mapping

PROCEDURERadiofrequency ablation of reccurent atrial arrythmia (standard of care)

Standard radiofrequncy ablation of reccurent atrial arrythmia following pulmonary vien isolation employing substrate modification strategy


Locations(1)

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

Wroclaw, Poland

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NCT07141745


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