Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)
Status: Completed
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years of age or older
• History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
• Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation
Locations
United States
Michigan
Michigan Heart, PC
Ypsilanti
Mississippi
Cardiology Associates Research, LLC
Tupelo
New York
Rochester Regional Health
Rochester
University of Rochester
Rochester
Time Frame
Start Date: 2020-06-25
Completion Date: 2024-02-15
Participants
Target number of participants: 55
Treatments
Active_comparator: Biotronik ICM-guided AF management
ICM obtained data will be actively used to guide and monitor treatment .
No_intervention: Conventional AF Management
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Biotronik, Inc.
Leads: University of Rochester