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HEAL-LAA Clinical Trial (HEAL-LAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05809596
Recruitment Status : Recruiting
First Posted : April 12, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Bleeding Stroke Device: WATCHMAN FLX Pro LAAC Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
Actual Study Start Date : October 3, 2023
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : June 30, 2025
Arms and Interventions
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Arm Intervention/treatment
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 Name: Left Atrial Appendage Closure


Outcome Measures
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Primary Outcome Measures :
  1. The rate of leak (>5 mm) for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than the rate of leak (> 5mm) of the performance goal. [ Time Frame: 45 days ]
    Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.

  2. The composite rate of all-cause mortality, all stroke, systemic embolism, and major bleeding for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than a performance goal. [ Time Frame: 6 months ]
    Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05809596


Contacts
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Contact: Angela Schutt 1-800-CARDIAC angela.schutt@bsci.com

Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Mohamed Kanj, MD The Cleveland Clinic
Principal Investigator: Oluseun Alli, MD Novant Health Heart & Vascular Institute
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT05809596    
Other Study ID Numbers: s2504
First Posted: April 12, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
URL: http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes