HEAL-LAA Clinical Trial (HEAL-LAA)

HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Bleeding
• Intervention / Treatment: Device: WATCHMAN FLX Pro LAAC Device

• Study Type: Interventional
• Enrollment (Actual): 949
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Medical Center
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center/ Affinity Cardiovascular Specialists
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • La Jolla, California, United States, 92307
      • Scripps Memorial Hospital
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Thousand Oaks, California, United States, 91360
      • Los Robles Hospital & Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • UC Health Memorial Hospital Central
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Cardiology Associates of Fairfield County, P.C.
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34205
      • Manatee Memorial Hospital
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory University
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Straub Medical Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Heart and Vascular Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Corewell Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Health System
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Health
  • New York
    • Buffalo, New York, United States, 14203
      • Kaleida Health - Gates Vascular Institute
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart & Vascular Institute
    • Charlotte, North Carolina, United States, 28204
      • Sanger Heart and Vascular Institute-Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Mechanicsburg, Pennsylvania, United States, 17050
      • UPMC Pinnacle Health at Harrisburg Hospital
    • York, Pennsylvania, United States, 17403
      • Wellspan York Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health, Inc.,
    • Germantown, Tennessee, United States, 38138
      • Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
    • Nashville, Tennessee, United States, 37203
      • Ascension Saint Thomas
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
    • Houston, Texas, United States, 77094
      • Memorial Hermann Memorial City Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • St. Mark's Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Device Group; WATCHMAN FLX Pro LAAC Device Implantation	Device: WATCHMAN FLX Pro LAAC Device; Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device; Other Names: Left Atrial Appendage Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects	Incomplete seal with peri-device gap > 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).	45 days
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects	Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.	6 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Mohamed Kanj, MD, The Cleveland Clinic; Principal Investigator: Oluseun Alli, MD, Novant Health Heart & Vascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): September 18, 2025

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage; Investigative Techniques; Therapeutics; Catheterization; Cardiac Catheterization; Left Atrial Appendage Closure
• Other Study ID Numbers: s2504 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy ( https://www.bostonscientific.com/en-US/data-sharing-requests.html).
• IPD Sharing Time Frame: 12 to 18 months following the end of the clinical trial. Estimated start Q4 2025, estimated end date Q4 2026-Q2 2027
• IPD Sharing Access Criteria: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy ( https://www.bostonscientific.com/en-US/data-sharing-requests.html).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes