Clinical trial NCT05809596: HEAL-LAA Clinical Trial
Official title: HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Bleeding
Stroke
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 949
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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.
timeFrame: 45 days
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center/ Affinity Cardiovascular Specialists
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital & Medical Center
state: California
city: Colorado Springs
country: United States
facility: UC Health Memorial Hospital Central
state: Colorado
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County, P.C.
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Straub Medical Center
state: Hawaii
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Community Heart and Vascular Hospital
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Kaleida Health - Gates Vascular Institute
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart & Vascular Institute
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute-Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mechanicsburg
country: United States
facility: UPMC Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: York
country: United States
facility: WellSpan York Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Health, Inc.,
state: Tennessee
city: Germantown
country: United States
facility: Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Ascension Saint Thomas
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Memorial City Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances
state: Texas
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: The Cleveland Clinic
name: Mohamed Kanj, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Novant Health Heart & Vascular Institute
name: Oluseun Alli, MD
role: PRINCIPAL_INVESTIGATOR
References: