HEAL-LAA Clinical Trial

Last updated: June 17, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Chest Pain

Treatment

WATCHMAN FLX Pro LAAC Device

Clinical Study ID

NCT05809596
s2504
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is of legal age to participate in the study.

  • Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillationin 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 aWATCHMAN FLX™ Pro device.

  • Subject or legal representative is able to understand and willing to provide writteninformed consent to participate in the study.

  • Subject is able and willing to return for required follow-up visits andexaminations.

Exclusion

Exclusion Criteria:

  • Subject has a documented life expectancy of less than 6 months.

  • Subject is currently enrolled in another investigational study, except if thesubject is participating in a mandatory governmental registry, or a purelyobservational registry with no associated treatment.

  • Intracardiac thrombus is present.

  • An atrial septal defect repair or closure device or a patent foramen ovale repair orclosure 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 theindividual components such that the use of the WATCHMAN FLX™ Pro Device iscontraindicated.

  • Any of the customary contraindications for other percutaneous catheterizationprocedure (e.g., patient size too small to accommodate transesophagealechocardiography (TEE) probe or required catheters) or conditions (e.g., activeinfection, bleeding disorder) are present.

  • There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12inhibitor.

  • Subject is of childbearing potential and is, or plans to become, pregnant during thetime of the study (method of assessment per study physician's discretion).

Study Design

Total Participants: 949
Treatment Group(s): 1
Primary Treatment: WATCHMAN FLX Pro LAAC Device
Phase:
Study Start date:
October 03, 2023
Estimated Completion Date:
August 30, 2025

Connect with a study center

  • Grandview Medical Center/ Affinity Cardiovascular Specialists

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • University of Alabama Medical Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Tucson Medical Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Scripps Memorial Hospital

    La Jolla, California 92307
    United States

    Site Not Available

  • Good Samaritan Hospital

    Los Angeles, California 90017
    United States

    Site Not Available

  • Eisenhower Medical Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Los Robles Hospital & Medical Center

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • UC Health Memorial Hospital Central

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County, P.C.

    Norwalk, Connecticut 06851
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Manatee Memorial Hospital

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Ascension St. Vincent's Medical Center

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Straub Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • MercyOne Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • University of Kansas Health System

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Saint Luke's Health System

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Virtua Health

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Kaleida Health - Gates Vascular Institute

    Buffalo, New York 14203
    United States

    Site Not Available

  • Rochester General Hospital

    Rochester, New York 14621
    United States

    Site Not Available

  • Novant Health Heart & Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute-Carolinas Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • UPMC Pinnacle Health at Harrisburg Hospital

    Mechanicsburg, Pennsylvania 17050
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • WellSpan York Hospital

    York, Pennsylvania 17403
    United States

    Site Not Available

  • Erlanger Health, Inc.,

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Ascension Saint Thomas

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research

    Austin, Texas 78705
    United States

    Site Not Available

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas 77094
    United States

    Site Not Available

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Christus Trinity Mother Frances

    Tyler, Texas 75701
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Site Not Available

  • St. Mark's Hospital

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

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