HEAL-LAA Clinical Trial

Stroke Clinical Trial

— HEAL-LAA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809596
• Other study ID #: s2504
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: Angela Schutt
• Phone: 1-800-CARDIAC
• Email: angela.schutt[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bleeding
• Stroke

Intervention

Device:
• WATCHMAN FLX Pro LAAC Device
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	Grandview Medical Center/ Affinity Cardiovascular Specialists	Birmingham	Alabama
United States	University of Alabama Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Kaleida Health - Gates Vascular Institute	Buffalo	New York
United States	Novant Health Heart & Vascular Institute	Charlotte	North Carolina
United States	Sanger Heart and Vascular Institute-Carolinas Medical Center	Charlotte	North Carolina
United States	Erlanger Health, Inc.,	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	UC Health Memorial Hospital Central	Colorado Springs	Colorado
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Corewell Health	Grand Rapids	Michigan
United States	Straub Medical Center	Honolulu	Hawaii
United States	Memorial Hermann Memorial City Medical Center	Houston	Texas
United States	Community Heart and Vascular Hospital	Indianapolis	Indiana
United States	Ascension St. Vincent's Medical Center	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Saint Luke's Health System	Kansas City	Missouri
United States	University of Kansas Health System	Kansas City	Kansas
United States	Scripps Memorial Hospital	La Jolla	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	Virtua Health	Marlton	New Jersey
United States	UPMC Pinnacle Health at Harrisburg Hospital	Mechanicsburg	Pennsylvania
United States	Intermountain Medical Center	Murray	Utah
United States	Ascension Saint Thomas	Nashville	Tennessee
United States	Centennial Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Cardiology Associates of Fairfield County, P.C.	Norwalk	Connecticut
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	St. Mark's Hospital	Salt Lake City	Utah
United States	Methodist Hospital	San Antonio	Texas
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Los Robles Hospital & Medical Center	Thousand Oaks	California
United States	Tucson Medical Center	Tucson	Arizona
United States	Christus Trinity Mother Frances	Tyler	Texas
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	MercyOne Iowa Heart Center	West Des Moines	Iowa
United States	WellSpan York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.	45 days
Primary	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.	Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.	6 months