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

Condition(s) studied

Investigational drug(s) / intervention(s)

Pulsed 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

Radiofrequency ablation of reccurent atrial arrythmia (standard of care): Standard radiofrequncy ablation of reccurent atrial arrythmia following pulmonary vien isolation employing substrate modification strategy

Study 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

Primary outcome measure(s)

• Freedom from atrial arrythmia in 12 month observation period — 12 months observation
  PFA is non-inferior to RFA in achieving freedom from documented atrial arrhythmia (AF, atrial flutter, or atrial tachycardia) lasting ≥30 seconds at 12 months after the index ablation procedure, as assessed by 12-lead ECG, 24-hour Holter monitoring, or symptomatic ECG recordings.

Trial sites (1)

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