HEAL-LAA Clinical Trial

Last updated: October 30, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Arrhythmia

Cerebral Ischemia

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:
September 18, 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

  • Grandview Medical Center/ Affinity Cardiovascular Specialists

    Birmingham 4049979, Alabama 4829764 35243
    United States

    Site Not Available

  • University of Alabama Medical Center

    Birmingham 4049979, Alabama 4829764 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

  • Phoenix Cardiovascular Research Group

    Phoenix 5308655, Arizona 5551752 85018
    United States

    Site Not Available

  • Tucson Medical Center

    Tucson 5318313, Arizona 5551752 85712
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro 4116834, Arkansas 4099753 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

  • Scripps Memorial Hospital

    La Jolla 5363943, California 5332921 92307
    United States

    Site Not Available

  • Good Samaritan Hospital

    Los Angeles 5368361, California 5332921 90017
    United States

    Site Not Available

  • Eisenhower Medical Center

    Rancho Mirage 5386015, California 5332921 92270
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara 5392952, California 5332921 93105
    United States

    Site Not Available

  • Los Robles Hospital & Medical Center

    Thousand Oaks 5402405, California 5332921 91360
    United States

    Site Not Available

  • UC Health Memorial Hospital Central

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • UC Health Memorial Hospital Central

    Colorado Springs 5417598, Colorado 5417618 80909
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County, P.C.

    Norwalk, Connecticut 06851
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County, P.C.

    Norwalk 4839822, Connecticut 4831725 06851
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 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

  • Manatee Memorial Hospital

    Bradenton 4148708, Florida 4155751 34205
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota 4172131, Florida 4155751 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

  • Emory University

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah 4221552, Georgia 4197000 31404
    United States

    Site Not Available

  • Straub Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Straub Medical Center

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Site Not Available

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Community Heart and Vascular Hospital

    Indianapolis 4259418, Indiana 4921868 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

  • University of Kansas Health System

    Kansas City 4273837, Kansas 4273857 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

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids 4994358, Michigan 5001836 49525
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Saint Luke's Health System

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke's Health System

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • Virtua Health

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Virtua Health

    Marlton 4502911, New Jersey 5101760 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

  • Kaleida Health - Gates Vascular Institute

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

  • Rochester General Hospital

    Rochester 5134086, New York 5128638 14621
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    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

  • Novant Health Heart & Vascular Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute-Carolinas Medical Center

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 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

  • UPMC Pinnacle Health at Harrisburg Hospital

    Mechanicsburg 5200657, Pennsylvania 6254927 17050
    United States

    Site Not Available

  • WellSpan York Hospital

    York 4562407, Pennsylvania 6254927 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

  • Erlanger Health, Inc.,

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Site Not Available

  • Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Ascension Saint Thomas

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Centennial Medical Center

    Nashville 4644585, Tennessee 4662168 37203
    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

  • Texas Cardiac Arrhythmia Research

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Memorial Hermann Memorial City Medical Center

    Houston 4699066, Texas 4736286 77094
    United States

    Site Not Available

  • Methodist Hospital

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Christus Trinity Mother Frances

    Tyler 4738214, Texas 4736286 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

  • St. Mark's Hospital

    Salt Lake City 5780993, Utah 5549030 84124
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.