Actively Recruiting
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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods for repeat catheter ablation in patients with recurrent atrial fibrillation (AF): thermal energy ablation using radiofrequency (RF) and non-thermal electroporation called pulsed field ablation (PFA). This randomized clinical trial compares the safety and effectiveness of these two techniques, both guided by 3D imaging systems. The study focuses on patients who have experienced AF recurrence after prior pulmonary vein isolation treatment and require repeat ablation. Participants will be randomly assigned to receive either RF ablation or PFA. Both procedures involve high-resolution electroanatomical mapping of the left atrium to identify targets for ablation. After the energy delivery with the assigned technique, remapping is done to confirm success. No additional invasive procedures are required beyond the standard ablation. Follow-up visits are scheduled at 3, 6, and 12 months with medical history review, physical examination, 12-lead ECG, and 24-hour Holter monitoring. Extra ECG assessments are available if symptoms appear. During the study, participants will be closely monitored through routine clinical assessments and heart rhythm recordings. Data collected includes procedural details, heart anatomy, complications, and arrhythmia recurrence. Safety is monitored through adverse event tracking up to 90 days post-procedure. The main outcome is freedom from atrial arrhythmia over 12 months. The trial lasts up to one year of observation with structured follow-up visits to support early detection and management of any arrhythmias.
CONDITIONS
Brief Title
Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented recurrence of atrial fibrillation or atypical atrial flutter after prior pulmonary vein isolation
- Eligibility for repeat pulmonary vein isolation procedure
- Age between 18 and 85 years
- All genders 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo repeat pulmonary vein isolation using either pulsed field ablation (PFA) or radiofrequency ablation (RFA) guided by 3D electroanatomical mapping.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for safety and effectiveness with visits including medical history review, physical examination, ECG, and Holter monitoring.
3 visits at 3, 6, and 12 months with additional visits if symptoms occur
Trial Site Locations
Total: 1 location
1
Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw
Wroclaw, Poland, 50-556
Actively Recruiting
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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