RecruitingNot ApplicableNCT07390214
REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
Sponsor
Cardioangiologisches Centrum Bethanien
Enrollment
200 participants
Start Date
Dec 15, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF.
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Plain Language Summary
Simplified for easier understanding
This trial is comparing two types of catheter ablation tools for people whose atrial fibrillation (AF) or atrial tachycardia (a fast heart rhythm) has come back after a previous ablation procedure. One tool uses a newer system called AFFERA; the other is a traditional contact force-guided radiofrequency catheter. The goal is to find out which approach leads to better outcomes the second time around.
**You may be eligible if...**
- You are 18 to 85 years old
- You have had exactly one previous pulmonary vein isolation (PVI) ablation procedure for AF
- Your AF or fast atrial rhythm has returned despite that ablation
- You are willing and able to use a heart rhythm monitoring device at home
**You may NOT be eligible if...**
- You have had more than one previous ablation procedure targeting the pulmonary veins
- Your previous ablation treated additional areas beyond the pulmonary veins
- Your left atrium (upper left heart chamber) is enlarged (>55mm)
- You have had longstanding persistent AF (more than 12 months continuously)
- You have had surgical ablation of the heart before
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
PROCEDUREDual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas
Re-PVI
PROCEDURECF-guided RFC: Re-PVI and substrate modification of low voltage areas
Re-PVI
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07390214