REFOCUS-AF - RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431
RECRUITING
Frankfurt Am Main
Contact Information
Primary
Julian Chun, Professor
j.chun@ccb.de
+49 69 945028
Backup
Boris Schmidt, Professor
b.schmidt@ccb.de
+49 69 945028
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 200
Treatments
Experimental: CF-guided RFC: Re-PVI and substrate modification of low voltage areas
Patient get intervention via Contact force guided radiofrequency ablation
Experimental: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath
Patient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9)
Related Therapeutic Areas
Sponsors
Leads: Cardioangiologisches Centrum Bethanien