HEAL-LAA Clinical Trial

NCT05809596 | Completed Results FDA Device

• 1 other identifier: s2504
• Study Type: interventional
• Target: 949
• Locations: 1 country
• Sites: 45

Brief 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.

Conditions

Atrial Fibrillation; Bleeding; Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device Group

OTHER

WATCHMAN FLX Pro LAAC Device Implantation

Device: WATCHMAN FLX Pro LAAC Device

Interventions

WATCHMAN FLX Pro LAAC Device DEVICE

Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Also known as: Left Atrial Appendage Closure

Device Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (45)

University of Alabama Medical Center

Birmingham, Alabama, 35233, United States

Location

Grandview Medical Center/ Affinity Cardiovascular Specialists

Birmingham, Alabama, 35243, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92307, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

UC Health Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

Location

Cardiology Associates of Fairfield County, P.C.

Norwalk, Connecticut, 06851, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34205, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Emory University

Atlanta, Georgia, 30342, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Straub Medical Center

Honolulu, Hawaii, 96813, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

Location

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Corewell Health

Grand Rapids, Michigan, 49525, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Virtua Health

Marlton, New Jersey, 08053, United States

Location

Kaleida Health - Gates Vascular Institute

Buffalo, New York, 14203, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Novant Health Heart & Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

Sanger Heart and Vascular Institute-Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UPMC Pinnacle Health at Harrisburg Hospital

Mechanicsburg, Pennsylvania, 17050, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

Erlanger Health, Inc.,

Chattanooga, Tennessee, 37403, United States

Location

Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Ascension Saint Thomas

Nashville, Tennessee, 37203, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77094, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Christus Trinity Mother Frances

Tyler, Texas, 75701, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hemorrhage; Stroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Nicole Kelly, Clinical Trial Manager
• Organization: Boston Scientific

Nicole.Kelly2@bsci.com

1-800-CARDIAC

Study Officials

• Mohamed Kanj, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Oluseun Alli, MD

  Novant Health Heart & Vascular Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: October 3, 2023
• Primary Completion: July 15, 2024
• Study Completion: September 18, 2025
• Last Updated: November 4, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 to 18 months following the end of the clinical trial. Estimated start Q4 2025, estimated end date Q4 2026-Q2 2027
• 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).

Locations

US (45)