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

NCT07141745 | Recruiting

• 1 other identifier: SUBK.A460.25.068
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atrial fibrillation re-ablation; Pulsed Field Ablation; Radiofrequency Catheter Ablation; Atrial firbillation reccurence

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrythmia in 12 month observation period

  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.

  12 months observation

Secondary Outcomes (5)

• Comparison of skin-to-skin time between PFA and RFA group

  Data recorded during the procedure

• Comparison of total fluoroscopy time between PFA and RFA group

  Data recorded during the procedure

• Comparison of total ablation time between PFA and RFA group

  Data recorded during the procedure

• Comparison of total radiation dose between PFA and RFA group

  Data recorded during the procedure

• Safety endpoint

  Adverse events during the index procedure and within following 90 days

Study Arms (2)

PFA group

ACTIVE COMPARATOR

Patients in this arm will undergo 3D-mpping guided re-ablation with the PFA catheter

Procedure: Pulsed field ablation of reccurent atrial arrythmia

RFA group

ACTIVE COMPARATOR

Patients in this arm will undergo 3D-mpping guided re-ablation with RFA catheter

Procedure: Radiofrequency ablation of reccurent atrial arrythmia (standard of care)

Interventions

Pulsed field ablation of reccurent atrial arrythmia PROCEDURE

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

PFA group

Radiofrequency ablation of reccurent atrial arrythmia (standard of care) PROCEDURE

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

RFA group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented recurrence of AF or atypical atrial flutter after prior PVI Eligibility for re-PVI

You may not qualify if:

• Left ventricular ejection fraction \< 30% Left atrial volume index (LAVI) \> 72 mL/m² Untreated hyperthyroidism Hypertrophic cardiomyopathy Severe valvular heart disease

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

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

Wroclaw, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 26, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

PL (1)