HEAL-LAA Clinical Trial (HEAL-LAA)

• ClinicalTrials.gov Identifier: NCT05809596
• Recruitment Status: Recruiting
• First Posted: April 12, 2023
• Last Update Posted: May 17, 2024
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: March 30, 2023
• First Posted Date: April 12, 2023
• Last Update Posted Date: May 17, 2024
• Actual Study Start Date: October 3, 2023
• Estimated Primary Completion Date: August 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

• 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.
• 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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HEAL-LAA Clinical Trial
• Official Title: HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Atrial Fibrillation
• Bleeding
• Stroke

Intervention

Device: WATCHMAN FLX Pro LAAC Device

Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Other Name: Left Atrial Appendage Closure

Study Arms

Device Group

WATCHMAN FLX Pro LAAC Device Implantation

Intervention: Device: WATCHMAN FLX Pro LAAC Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2023): 1000
• Original Enrollment: Not Provided
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: August 30, 2024 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05809596
• Other Study ID Numbers: s2504
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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

• Current Responsible Party: Boston Scientific Corporation
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Boston Scientific Corporation
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

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

• PRS Account: Boston Scientific Corporation
• Verification Date: May 2024