Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• Patients who are determined by physicians to be eligible for LAAC
• Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure
• Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained)
Locations
United States
Alabama
Arrhythmia Institute at Grandview
RECRUITING
Birmingham
Florida
Arrhythmia Center of South Florida
RECRUITING
Delray Beach
Ascension St. Vincent's Jacksonville
NOT_YET_RECRUITING
Jacksonville
HCA Research Institute- Mercy Hospital
RECRUITING
Miami
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Indiana
Ascension St Vincent -Indianapolis Ascension Health
RECRUITING
Indianapolis
Kentucky
Norton Heart & Vascular Institute
NOT_YET_RECRUITING
Louisville
Pennsylvania
Allegheny General Hospital
RECRUITING
Pittsburgh
Texas
Texas Cardiac Arrhythmia Research Foundation
RECRUITING
Austin
Utah
St, Mark's Hospital
RECRUITING
Salt Lake City
Virginia
Chippenham Hospital)
NOT_YET_RECRUITING
Richmond
Contact Information
Primary
samantha S seepersad
sseepersad@hrcrs.com
3525720027
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 120
Treatments
Combining LAAC and PFA ablation procedures
AF ablation and LAAC procedures are performed per operators' standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. Both AF ablation and LAAC procedures may be performed with ICE or TEE. Assessment of LAAC peri-device leaks and device-related thrombi at 45-90 days may be performed with TEE or cardiac computed tomography angiography (CCTA).
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Heart Rhythm Clinical and Research Solutions, LLC