HEAL-LAA Clinical Trial

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Bleeding, Stroke

In brief

The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.

Key facts

Study ID

NCT05809596

Run by

Boston Scientific Corporation

People needed

949

Starts

2023-10-03

Expected to finish

2025-09-18

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is of legal age to participate in the study.
• Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
• Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
• Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
• Subject is able and willing to return for required follow-up visits and examinations.

You may not qualify if…

• Subject has a documented life expectancy of less than 6 months.
• Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
• Intracardiac thrombus is present.
• An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
• The LAA anatomy will not accommodate a Closure Device.
• The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated.
• Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
• There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
• Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).

Where it is running

• University of Alabama Medical Center — Birmingham, Alabama, United States
• Grandview Medical Center/ Affinity Cardiovascular Specialists — Birmingham, Alabama, United States
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Scripps Memorial Hospital — La Jolla, California, United States
• Good Samaritan Hospital — Los Angeles, California, United States
• Eisenhower Medical Center — Rancho Mirage, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Los Robles Hospital & Medical Center — Thousand Oaks, California, United States
• UC Health Memorial Hospital Central — Colorado Springs, Colorado, United States
• Cardiology Associates of Fairfield County, P.C. — Norwalk, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Straub Medical Center — Honolulu, Hawaii, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Community Heart and Vascular Hospital — Indianapolis, Indiana, United States
• University of Kansas Health System — Kansas City, Kansas, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Luke's Health System — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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