RecruitingNCT07041125

Concomitant LAAC/AF Ablation (Watchman FLX Pro)

Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)


Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Enrollment

120 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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)

Exclusion Criteria1

  • Patients who are participating in other DISRUPT-AF sub-studies

Interventions

DEVICEWatchman 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

View Full Details on ClinicalTrials.gov

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NCT07041125