Actively Recruiting
REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
Led by Cardioangiologisches Centrum Bethanien · Updated on 2026-02-05
200
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic non-valvular atrial fibrillation or atrial tachycardia recurrences after one previous pulmonary vein isolation catheter ablation
- Age 18 to 85 years
- Willing and able to comply with the study protocol
- Willing and able to operate a device for rhythm monitoring
You will not qualify if you...
- Contraindications to catheter ablation or inability to provide informed consent
- Patients who had pulmonary vein isolation plus ablation of additional right or left atrial areas
- Patients who never had pulmonary vein isolation before
- Patients who had more than one prior pulmonary vein isolation or repeat procedure
- Left atrial size greater than 55 mm
- Longstanding persistent atrial fibrillation longer than 12 months
- Prior surgical atrial fibrillation ablation
- Contraindications for repeat ablation
- Prior implantable loop recorder
- History of mitral valve surgery
- Severe mitral valve regurgitation
- Unable to be treated with oral anticoagulation
- Presence of intracardiac thrombi
- Chronic obstructive pulmonary disease or asthma treated with long-acting bronchodilators
- Obstructive sleep apnea requiring CPAP mask ventilation
- Pregnancy
- Participation in other clinical studies
- Unwillingness to follow the study protocol or attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431
Frankfurt am Main, Hesse, Germany, 60431
Actively Recruiting
Research Team
J
Julian Chun, Professor
CONTACT
B
Boris Schmidt, Professor
CONTACT
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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