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

NCT07141745 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-27

No results posted yet for this 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.

Conditions

  • Atrial Fibrillation (AF)
  • Ablation Techniques
  • Radiofrequency Catheter Ablation
  • Pulsed Field Ablation

Interventions

PROCEDURE

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

PROCEDURE

Radiofrequency ablation of reccurent atrial arrythmia (standard of care)

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

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2028-08-01
Completion
2028-10-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07141745 on ClinicalTrials.gov