Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

NCT03795298 | Completed Results DMC FDA Device

• 1 other identifier: S2239
• Study Type: interventional
• Target: 1,600
• Locations: 10 countries
• Sites: 114

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.

Conditions

Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation; Left atrial appendage; Ablation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism

  Occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism events adjudicated by an Independent Clinical Event Committee

  From randomization to 1095 days post randomization

• Primary Safety Endpoint: Non-procedural Bleeding

  Occurrence of non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) events adjudicated by an Independent Clinical Event Committee

  Non-procedural events are those occurring after 3 days, calculated from implant or attempted implant date for Device patients and from date of randomization for Control patients

Secondary Outcomes (1)

• ISTH Major Bleeding

  From randomization to 1095 days post randomization

Study Arms (2)

WATCHMAN FLX

EXPERIMENTAL

WATCHMAN FLX implant including modified post-implant drug regimen.

Device: WATCHMAN FLX Implant

Market-approved OAC

ACTIVE COMPARATOR

Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Drug: Market-approved OAC

Interventions

WATCHMAN FLX Implant DEVICE

Left atrial appendage closure with the WATCHMAN FLX device

WATCHMAN FLX

Market-approved OAC DRUG

Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Market-approved OAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (114)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Heart Center Research

Huntsville, Alabama, 35801, United States

Location

Alaska Regional Hospital

Anchorage, Alaska, 99508, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85016, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85016, United States

Location

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Heart Clinic Arkansas

Little Rock, Arkansas, 72205, United States

Location

Mills Peninsula Health Services

Burlingame, California, 94010, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Marin General Hospital

Larkspur, California, 94939, United States

Location

University of Southern California Hospital

Los Angeles, California, 90017, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

Location

Marian Regional Medical Center

Santa Maria, California, 93454, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Centura Health

Littleton, Colorado, 80120, United States

Location

Medical Center of the Rockies (Loveland)

Loveland, Colorado, 80538, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34205, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

AdventHealth Ocala

Ocala, Florida, 34471, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

St. Alphonsus Regional Medical Center

Boise, Idaho, 83704, United States

Location

St. Lukes Idaho Cardiology Associates

Boise, Idaho, 83712, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Methodist Hospital of Indianapolis

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

Overland Park Regional Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Kansas City Cardiac Arrhythmia Research

Overland Park, Kansas, 66215, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic Hospital

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MyMichigan Medical Center Midland

Midland, Michigan, 48670, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Mercy Research

St Louis, Missouri, 63141, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Northwell Health

Bay Shore, New York, 11706, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Saint Thomas Health

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

HeartPlace Mid-Cities EP

Bedford, Texas, 76021, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Cardiology Clinic of San Antonio

San Antonio, Texas, 78229, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75702, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

Chippenham Medical Center

Richmond, Virginia, 23225, United States

Location

CHI Franciscan Health System

Tacoma, Washington, 98405, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, 98664, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26506, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

Advara HeartCare

Brisbane, Queensland, 4120 QLD, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, East Flanders, 9300, Belgium

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

CHRU de Lille

Lille, Hauts-de-France, 59037, France

Location

CHRU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

Hospital Europeen Georges-Pompidou

Paris, 75015, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Centre Hôpital Universitaire Rangueil

Toulouse, 31400, France

Location

CHU Henri Mondor

Créteil, Île-de-France Region, 94010, France

Location

Hospital de la Pitie-Salpetriere

Paris, Île-de-France Region, 75013, France

Location

DHZC - Deutsches Herzzentrum der Charité

Berlin, 12203, Germany

Location

Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee

Berlin, 13353, Germany

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

Erfurt, 99097, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, 60431, Germany

Location

Universitatsklinik Greifswald

Greifswald, 17475, Germany

Location

Asklepios Klinik Saint Georg

Hamburg, 20099, Germany

Location

Allgemeines Krankenhaus Altona

Hamburg, 22763, Germany

Location

Klinikum St. Georg

Leipzig, 4129, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Lübeck, D-23538, Germany

Location

St. Josefs-Hospital GmbH

Wiesbaden, 65189, Germany

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

Torino, 10123, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

Poznan University of Medical Sciences

Poznan, 61-848, Poland

Location

Hospital General Universitario

Alicante, 3010, Spain

Location

Hospital Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Salamanca

Salamanca, 37007, Spain

Location

Clinico de Valladolid

Valladolid, 47005, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Related Publications (1)

• Wazni OM, Saliba WI, Nair DG, Marijon E, Schmidt B, Hounshell T, Ebelt H, Skurk C, Oza S, Patel C, Kanagasundram A, Sadhu A, Sundaram S, Osorio J, Mark G, Gupta M, DeLurgio DB, Olson J, Nielsen-Kudsk JE, Boersma LVA, Healey JS, Phillips KP, Asch FM, Wolski K, Roy K, Christen T, Sutton BS, Stein KM, Reddy VY; OPTION Trial Investigators. Left Atrial Appendage Closure after Ablation for Atrial Fibrillation. N Engl J Med. 2025 Apr 3;392(13):1277-1287. doi: 10.1056/NEJMoa2408308. Epub 2024 Nov 16.

  PMID: 39555822 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study had several exclusion criteria and results may not be applicable to the excluded populations. Pulsed field ablation was not available at the time of the trial. Although type of ablation technology used is unlikely to affect antithrombotic strategy, any unique considerations for this ablation method could not be investigated in the present study.

Results Point of Contact

• Title: Anne Cornaille
• Organization: Boston Scientific

anne.cornaille@bsci.com

+1-800-227-3422

Study Officials

• Oussama Wazni, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 7, 2019
• Study Start: May 20, 2019
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1); DE (11); IT (2); PL (1); ES (6); AU (2); NL (1); BE (1); US (81); FR (8)