Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
- Conditions
- Atrial Fibrillation
- Interventions
- Device: WATCHMAN FLX ImplantDrug: Market-approved OAC
- Registration Number
- NCT03795298
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
- Detailed Description
This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.
A subject who signs informed consent is considered enrolled in the study. Subjects will be randomized to OAC or WATCHMAN FLX in equal fashion. Randomization will be stratified by sequential vs. concomitant planned ablation +/- WATCHMAN implantation, to help ensure balance of treatment assignments within the sequential and concomitant groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
- The subject is of legal age to participate in the study per the laws of their respective geography.
- Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).
- The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
- The subject is deemed to be suitable for the defined protocol pharmacologic regimen.
- The subject is able to undergo TEE examinations.
- The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
- The subject is able and willing to return for required follow-up visits and examinations.
- The subject is currently enrolled in another investigational study that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
- The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy).
- The subject is deemed by the treating physician to be unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons.
- The subject had or is planning to have any cardiac or major non-cardiac interventional or surgical procedure (excluding non-valvular AF ablation and cardioversion) within 30 days prior to or 60 days after randomization [including, but not limited to: percutaneous coronary intervention (PCI), other cardiac ablation (VT ablation, etc.), etc.].
- The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization.
- The subject had a prior major bleeding event per ISTH definition within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
- The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.
- The subject has a history of atrial septal repair or has an ASD/PFO device.
- The subject has an implanted mechanical valve prosthesis in any position.
- The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion)
- The subject has a documented life expectancy of less than two years.
- The subject has a cardiac tumor.
- The subject has signs/symptoms of acute or chronic pericarditis.
- There is evidence of tamponade physiology.
- Contraindications (anatomical or medical) to percutaneous catheterization procedures.
- The subject has documented NYHA Class IV heart failure.
- The subject has documented surgical closure of the left atrial appendage.
- The subject has an active infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WATCHMAN FLX WATCHMAN FLX Implant WATCHMAN FLX implant including modified post-implant drug regimen. Market-approved OAC Market-approved OAC Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
- Primary Outcome Measures
Name Time Method Stroke, all cause death, and systemic embolism 36 months WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.
Non-procedural bleeding 36 months WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).
- Secondary Outcome Measures
Name Time Method Major bleeding 36 months WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).
Trial Locations
- Locations (114)
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
York Hospital
🇺🇸York, Pennsylvania, United States
University of Southern California Hospital
🇺🇸Los Angeles, California, United States
Methodist Hospital of Indianapolis
🇺🇸Indianapolis, Indiana, United States
Cardiology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
CHU Henri Mondor
🇫🇷Créteil, Île-de-France, France
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, East Flanders, Belgium
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Utrecht, Netherlands
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
St. Mark's Hospital
🇺🇸Salt Lake City, Utah, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
Alaska Regional Hospital
🇺🇸Anchorage, Alaska, United States
Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Mills Peninsula Health Services
🇺🇸Burlingame, California, United States
St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Marin General Hospital
🇺🇸Larkspur, California, United States
Centura Health
🇺🇸Littleton, Colorado, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Marian Regional Medical Center
🇺🇸Santa Maria, California, United States
Kaiser Permanente Santa Clara Medical Center
🇺🇸Santa Clara, California, United States
Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
Medical Center of the Rockies (Loveland)
🇺🇸Loveland, Colorado, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
AdventHealth Ocala
🇺🇸Ocala, Florida, United States
St. Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Edward Hospital
🇺🇸Naperville, Illinois, United States
St. Lukes Idaho Cardiology Associates
🇺🇸Boise, Idaho, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Overland Park Regional Medical Center
🇺🇸Kansas City, Kansas, United States
Kansas City Cardiac Arrhythmia Research
🇺🇸Overland Park, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Northwell Health
🇺🇸Bay Shore, New York, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
New York University Medical Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Lindner Center for Research and Education at Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Pinnacle Health at Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
Presbyterian University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
HeartPlace Mid-Cities EP
🇺🇸Bedford, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Chippenham Medical Center
🇺🇸Richmond, Virginia, United States
Advara HeartCare
🇦🇺Brisbane, Queensland, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Monongalia General Hospital
🇺🇸Morgantown, West Virginia, United States
Aarhus University Hospital
🇩🇰Aarhus, Denmark
CHRU de Lille
🇫🇷Lille, Hauts-de-France, France
CHU Grenoble - Hopital Michallon
🇫🇷Grenoble, France
CHRU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Hospital de la Pitie-Salpetriere
🇫🇷Paris, Ile-de-France, France
Hospital Europeen Georges-Pompidou
🇫🇷Paris, France
Centre Hôpital Universitaire Rangueil
🇫🇷Toulouse, France
Asklepios Klinik Saint Georg
🇩🇪Hamburg, Germany
Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee
🇩🇪Berlin, Germany
Clinique Pasteur
🇫🇷Toulouse, France
DHZC - Deutsches Herzzentrum der Charité
🇩🇪Berlin, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Germany
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
🇩🇪Erfurt, Germany
Allgemeines Krankenhaus Altona
🇩🇪Hamburg, Germany
Universitatsklinik Greifswald
🇩🇪Greifswald, Germany
Klinikum St. Georg
🇩🇪Leipzig, Germany
Centro Cardiologico Monzino
🇮🇹Milano, Italy
St. Josefs-Hospital GmbH
🇩🇪Wiesbaden, Germany
Universitaetsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Poznan University of Medical Sciences
🇵🇱Poznan, Poland
Hospital General Universitario
🇪🇸Alicante, Spain
Hospital Puerta Del Mar
🇪🇸Cadiz, Spain
Clinico de Valladolid
🇪🇸Valladolid, Spain
Hospital Clinico Salamanca
🇪🇸Salamanca, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Spain
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Christus Trinity Mother Frances Health System
🇺🇸Tyler, Texas, United States
MyMichigan Medical Center Midland
🇺🇸Midland, Michigan, United States
CHI Franciscan Health System
🇺🇸Tacoma, Washington, United States
Lahey Clinic Hospital
🇺🇸Burlington, Massachusetts, United States
Mercy Research
🇺🇸Saint Louis, Missouri, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
PeaceHealth Southwest Medical
🇺🇸Vancouver, Washington, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States