Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07141745

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

Led by Wroclaw Medical University · Updated on 2025-08-27

250

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented recurrence of atrial fibrillation or atypical atrial flutter after prior pulmonary vein isolation
  • Eligible for repeat pulmonary vein isolation
  • Age between 18 and 85 years
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction less than 30%
  • Left atrial volume index greater than 72 mL/m²
  • Untreated hyperthyroidism
  • Hypertrophic cardiomyopathy
  • Severe valvular heart disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Wroclaw, Poland, 50-556

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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