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Concomitant LAAC/AF Ablation (Watchman FLX Pro)
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
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).
Official title: Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-06-01
Completion Date
2026-10-30
Last Updated
2025-09-24
Healthy Volunteers
Not specified
Conditions
Interventions
Watchman FLX™ Pro device.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Locations (11)
Arrhythmia Institute at Grandview
Birmingham, Alabama, United States
Arrhythmia Center of South Florida
Delray Beach, Florida, United States
Ascension St. Vincent's Jacksonville
Jacksonville, Florida, United States
HCA Research Institute- Mercy Hospital
Miami, Florida, United States
Ascension St Vincent -Indianapolis Ascension Health
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Heart & Vascular Institute
Louisville, Kentucky, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
St, Mark's Hospital
Salt Lake City, Utah, United States
Chippenham Hospital)
Richmond, Virginia, United States