HEAL-LAA Clinical Trial (HEAL-LAA)

October 30, 2025 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
949

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 45 days
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
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Kanj, MD, The Cleveland Clinic
  • Principal Investigator: Oluseun Alli, MD, Novant Health Heart & Vascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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