Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-06-01
2026-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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).
Watchman FLX™ Pro device.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Interventions
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Watchman FLX™ Pro device.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Heart Rhythm Clinical and Research Solutions, LLC
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ALIGN-AF
Identifier Type: -
Identifier Source: org_study_id
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