HEAL-LAA Clinical Trial
- Conditions
- Atrial FibrillationStrokeBleeding
- Interventions
- Device: WATCHMAN FLX Pro LAAC Device
- Registration Number
- NCT05809596
- Lead Sponsor
- Boston Scientific Corporation
- 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 available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 949
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device Group WATCHMAN FLX Pro LAAC Device WATCHMAN FLX Pro LAAC Device Implantation
- Primary Outcome Measures
Name Time Method 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. 6 months Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
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. 45 days Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
University of Alabama Medical Center
🇺🇸Birmingham, Alabama, United States
Grandview Medical Center/ Affinity Cardiovascular Specialists
🇺🇸Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Sanger Heart and Vascular Institute-Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UPMC Pinnacle Health at Harrisburg Hospital
🇺🇸Mechanicsburg, Pennsylvania, United States
WellSpan York Hospital
🇺🇸York, Pennsylvania, United States
Erlanger Health, Inc.,
🇺🇸Chattanooga, Tennessee, United States
Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Ascension Saint Thomas
🇺🇸Nashville, Tennessee, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Memorial Hermann Memorial City Medical Center
🇺🇸Houston, Texas, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Christus Trinity Mother Frances
🇺🇸Tyler, Texas, United States
St. Mark's Hospital
🇺🇸Salt Lake City, Utah, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Los Robles Hospital & Medical Center
🇺🇸Thousand Oaks, California, United States
UC Health Memorial Hospital Central
🇺🇸Colorado Springs, Colorado, United States
Cardiology Associates of Fairfield County, P.C.
🇺🇸Norwalk, Connecticut, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Straub Medical Center
🇺🇸Honolulu, Hawaii, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Community Heart and Vascular Hospital
🇺🇸Indianapolis, Indiana, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Luke's Health System
🇺🇸Kansas City, Missouri, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Virtua Health
🇺🇸Marlton, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Kaleida Health - Gates Vascular Institute
🇺🇸Buffalo, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Novant Health Heart & Vascular Institute
🇺🇸Charlotte, North Carolina, United States