Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation (OPTION)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: WATCHMAN FLX Implant; Drug: Market-approved OAC

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.

• Study Type: Interventional
• Enrollment (Actual): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4120 QLD
      • Advara HeartCare
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
• Belgium
  • East Flanders
    • Aalst, East Flanders, Belgium, 9300
      • Onze Lieve Vrouw Ziekenhuis
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
• France
  • Clermont-Ferrand, France, 63000
    • CHRU de Clermont-Ferrand
  • Grenoble, France, 38043
    • CHU Grenoble - Hôpital MICHALLON
  • Paris, France, 75015
    • Hospital Europeen Georges-Pompidou
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France, 31400
    • Centre Hôpital Universitaire Rangueil
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59037
      • CHRU de Lille
  • Île-de-France Region
    • Créteil, Île-de-France Region, France, 94010
      • Chu Henri Mondor
    • Paris, Île-de-France Region, France, 75013
      • Hospital de la Pitie-Salpetriere
• Germany
  • Berlin, Germany, 12203
    • DHZC - Deutsches Herzzentrum der Charité
  • Berlin, Germany, 13353
    • Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee
  • Coburg, Germany, 96450
    • Klinikum Coburg GmbH
  • Erfurt, Germany, 99097
    • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
  • Frankfurt, Germany, 60431
    • Cardioangiologisches Centrum Bethanien
  • Greifswald, Germany, 17475
    • Universitatsklinik Greifswald
  • Hamburg, Germany, 20099
    • Asklepios Klinik Saint Georg
  • Hamburg, Germany, 22763
    • Allgemeines Krankenhaus Altona
  • Leipzig, Germany, 4129
    • Klinikum St. Georg
  • Lübeck, Germany, D-23538
    • Universitaetsklinikum Schleswig-Holstein
  • Wiesbaden, Germany, 65189
    • St. Josefs-Hospital GmbH
• Italy
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino
  • Torino, Italy, 10123
    • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3430 EM
      • St. Antonius Ziekenhuis
• Poland
  • Poznan, Poland, 61-848
    • Poznan University of Medical Sciences
• Spain
  • Alicante, Spain, 3010
    • Hospital General Universitario
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Salamanca, Spain, 37007
    • Hospital Clinico Salamanca
  • Valladolid, Spain, 47005
    • Clínico de Valladolid
  • Vigo, Spain, 36312
    • Hospital Alvaro Cunqueiro
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Regional Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Arrhythmia Research Center
    • Phoenix, Arizona, United States, 85016
      • Phoenix Cardiovascular Research Group
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernard's Medical Center
    • Little Rock, Arkansas, United States, 72205
      • Heart Clinic Arkansas
  • California
    • Burlingame, California, United States, 94010
      • Mills Peninsula Health Services
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
    • Larkspur, California, United States, 94939
      • Marin General Hospital
    • Los Angeles, California, United States, 90017
      • University of Southern California Hospital
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara Medical Center
    • Santa Maria, California, United States, 93454
      • Marian Regional Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital
    • Littleton, Colorado, United States, 80120
      • Centura Health
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies (Loveland)
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34205
      • Manatee Memorial Hospital
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • Ocala, Florida, United States, 34471
      • AdventHealth Ocala
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Lukes Idaho Cardiology Associates
    • Boise, Idaho, United States, 83704
      • St. Alphonsus Regional Medical Center
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Edward Hospital
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital of Indianapolis
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
    • Kansas City, Kansas, United States, 66160
      • Overland Park Regional Medical Center
    • Overland Park, Kansas, United States, 66215
      • Kansas City Cardiac Arrhythmia Research
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Midland, Michigan, United States, 48670
      • MyMichigan Medical Center Midland
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
    • St Louis, Missouri, United States, 63141
      • Mercy Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health
    • New York, New York, United States, 10016
      • New York University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Center for Research and Education at Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health at Harrisburg Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Presbyterian University of Pennsylvania Medical Center
    • Pittsburgh, Pennsylvania, United States, 15237
      • University of Pittsburgh Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Health
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
    • Bedford, Texas, United States, 76021
      • HeartPlace Mid-Cities EP
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78229
      • Cardiology Clinic of San Antonio
    • Tyler, Texas, United States, 75702
      • Christus Trinity Mother Frances Health System
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84124
      • St. Mark's Hospital
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Chippenham Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • CHI Franciscan Health System
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals
    • Morgantown, West Virginia, United States, 26506
      • Monongalia General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is of legal age to participate in the study per the laws of their respective geography.
2. 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).
3. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen.
5. The subject is able to undergo TEE examinations.
6. The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
7. The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

1. 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.
2. 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).
3. 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.
4. 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.].
5. The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization.
6. 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.
7. 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.
8. The subject has a history of atrial septal repair or has an ASD/PFO device.
9. The subject has an implanted mechanical valve prosthesis in any position.
10. 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)
11. The subject has a documented life expectancy of less than two years.
12. The subject has a cardiac tumor.
13. The subject has signs/symptoms of acute or chronic pericarditis.
14. There is evidence of tamponade physiology.
15. Contraindications (anatomical or medical) to percutaneous catheterization procedures.
16. The subject has documented NYHA Class IV heart failure.
17. The subject has documented surgical closure of the left atrial appendage.
18. The subject has an active infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WATCHMAN FLX; WATCHMAN FLX implant including modified post-implant drug regimen.	Device: WATCHMAN FLX Implant; Left atrial appendage closure with the WATCHMAN FLX device
Active Comparator: Market-approved OAC; Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.	Drug: Market-approved OAC; Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISTH Major Bleeding	Occurence of ISTH major bleeding (including procedural bleeding) events adjudicated by an Independent Clinical Event Committee	From randomization to 1095 days post randomization

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Oussama Wazni, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ablation; Non-valvular atrial fibrillation; Left atrial appendage
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: S2239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes