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
Inclusion Criteria2
- Patients with symptomatic non-valvular AF or AT recurrences despite of one previous PVI (+/- cavotricuspid isthmus ablation) catheter ablation for AF.
- Age 18-85 years Willing and able to comply with the study protocol Willing and able to operate a device for rhythm monitoring
Exclusion Criteria1
- Patients with contraindications to catheter ablation or inability to provide informed consent Patients who underwent PVI + (ablation of additional RA/LA substrates/areas) Patients who did not undergo PVI before Patients who underwent more than one prior PVI/Re-PVI Patients with left atrial size \> 55mm Patients with longstanding persistent AF \> 12 months duration Prior surgical AF ablation Contraindications for repeat ablation Prior implantable loop recorder History of mitral valve surgery Severe mitral valve regurgitation Inability to be treated with oral anticoagulation Presence of intracardiac thrombi Chronic obstructive pulmonary disease or Asthma treated with long acting bronchodilatators Obstructive sleep apnea syndrome requiring CPAP mask ventilation Pregnancy Participation in other clinical studies Unwilling to follow the study protocol and to attend follow-up visits
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