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

Plain Language Summary

Simplified for easier understanding

This sub-study is looking at patients who undergo two heart procedures at the same time: a procedure to close off a small pocket in the heart called the left atrial appendage (to reduce stroke risk) and a procedure to correct an abnormal heart rhythm called atrial fibrillation (AF ablation). The Watchman FLX Pro device is used for the closure. The study aims to understand how safe and effective this combined approach is. **You may be eligible if...** - Your cardiologist has determined you are a good candidate for a left atrial appendage closure procedure - Your closure procedure is being done at the same time as an atrial fibrillation (AF) ablation procedure - You are willing to provide extra consent for participation in this sub-study **You may NOT be eligible if...** - You do not meet the standard criteria for left atrial appendage closure - The procedures are not being done at the same time - You are not willing to consent to the additional sub-study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


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