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Atrial FibrillationOPTIONNCT03795298

Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

A study testing WATCHMAN FLX Implant and Market-approved OAC in people with Atrial Fibrillation, run by Boston Scientific Corporation at 114 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
WATCHMAN FLX Implant and Market-approved OAC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
114 sitesin 10 countries
Study dates
20 May 2019to 24 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

114 sites in 10 countries.

114 sites in 10 countries

United States81 sites

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705

  • Northwell Health

    Bay Shore, New York, 11706

  • HeartPlace Mid-Cities EP

    Bedford, Texas, 76021

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83704

  • St. Lukes Idaho Cardiology Associates

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Manatee Memorial Hospital

    Bradenton, Florida, 34205

  • Mills Peninsula Health Services

    Burlingame, California, 94010

  • Lahey Clinic Hospital

    Burlington, Massachusetts, 01805

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Iowa Heart Center

    Des Moines, Iowa, 50266

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Pinnacle Health at Harrisburg Hospital

    Harrisburg, Pennsylvania, 17101

  • Heart Center Research

    Huntsville, Alabama, 35801

  • Methodist Hospital of Indianapolis

    Indianapolis, Indiana, 46202

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401

  • Overland Park Regional Medical Center

    Kansas City, Kansas, 66160

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • Marin General Hospital

    Larkspur, California, 94939

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Heart Clinic Arkansas

    Little Rock, Arkansas, 72205

  • Centura Health

    Littleton, Colorado, 80120

  • University of Southern California Hospital

    Los Angeles, California, 90017

  • Medical Center of the Rockies (Loveland)

    Loveland, Colorado, 80538

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Monongalia General Hospital

    Morgantown, West Virginia, 26506

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Edward Hospital

    Naperville, Illinois, 60540

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Saint Thomas Health

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • New York University Medical Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • AdventHealth Ocala

    Ocala, Florida, 34471

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Kansas City Cardiac Arrhythmia Research

    Overland Park, Kansas, 66215

  • Presbyterian University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85016

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15237

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Rex Hospital

    Raleigh, North Carolina, 27607

  • Chippenham Medical Center

    Richmond, Virginia, 23225

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

  • Cardiology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Kaiser Permanente Santa Clara Medical Center

    Santa Clara, California, 95051

  • Marian Regional Medical Center

    Santa Maria, California, 93454

  • St. John's Hospital

    Springfield, Illinois, 62701

  • Mercy Research

    St Louis, Missouri, 63141

  • CHI Franciscan Health System

    Tacoma, Washington, 98405

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Christus Trinity Mother Frances Health System

    Tyler, Texas, 75702

  • PeaceHealth Southwest Medical

    Vancouver, Washington, 98664

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Germany11 sites

  • DHZC - Deutsches Herzzentrum der Charité

    Berlin, 12203

  • Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee

    Berlin, 13353

  • Klinikum Coburg GmbH

    Coburg, 96450

  • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

    Erfurt, 99097

  • Cardioangiologisches Centrum Bethanien

    Frankfurt, 60431

  • Universitatsklinik Greifswald

    Greifswald, 17475

  • Asklepios Klinik Saint Georg

    Hamburg, 20099

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Klinikum St. Georg

    Leipzig, 4129

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck, D-23538

  • St. Josefs-Hospital GmbH

    Wiesbaden, 65189

Other trials in Germany

France8 sites

  • CHRU de Clermont-Ferrand

    Clermont-Ferrand, 63000

  • CHU Henri Mondor

    Créteil, Île-de-France Region, 94010

  • CHU Grenoble - Hopital Michallon

    Grenoble, 38043

  • CHRU de Lille

    Lille, Hauts-de-France, 59037

  • Hospital Europeen Georges-Pompidou

    Paris, 75015

  • Hospital de la Pitie-Salpetriere

    Paris, Île-de-France Region, 75013

  • Clinique Pasteur

    Toulouse, 31076

  • Centre Hôpital Universitaire Rangueil

    Toulouse, 31400

Other trials in France

Spain6 sites

  • Hospital General Universitario

    Alicante, 3010

  • Hospital Puerta Del Mar

    Cadiz, 11009

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Clinico Salamanca

    Salamanca, 37007

  • Clinico de Valladolid

    Valladolid, 47005

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Australia2 sites

  • Advara HeartCare

    Brisbane, Queensland, 4120 QLD

  • Monash Health

    Clayton, Victoria, 3168

Other trials in Australia

Italy2 sites

  • Centro Cardiologico Monzino

    Milan, 20138

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

    Torino, 10123

Other trials in Italy

Belgium1 site

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, East Flanders, 9300

Other trials in Belgium

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

Netherlands1 site

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht, 3430 EM

Other trials in Netherlands

Poland1 site

  • Poznan University of Medical Sciences

    Poznan, 61-848

Other trials in Poland

About this study

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.

Read the 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.

Being tested
WATCHMAN FLX Implant, Market-approved OAC
Keywords
Non-valvular atrial fibrillation, Left atrial appendage, Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMAN FLX ImplantDevice

    Left atrial appendage closure with the WATCHMAN FLX device

  • Market-approved OACDrug

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

Study groups in NCT03795298
Study groupRoleWhat they receive
WATCHMAN FLXExperimentalWATCHMAN FLX implant including modified post-implant drug regimen.
Receives: Device: WATCHMAN FLX Implant
Market-approved OACActive comparatorUsed per IFU for atrial fibrillation stroke prevention for the duration of the trial.
Receives: Drug: Market-approved OAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From randomization to 1095 days post randomization

  2. 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

    Measured: 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)

  1. ISTH Major Bleeding

    Occurence of ISTH major bleeding (including procedural bleeding) events adjudicated by an Independent Clinical Event Committee

    Measured: From randomization to 1095 days post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2019
  2. Study start20 May 2019
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795298
Sponsor's protocol ID
S2239
Acronym
OPTION
Status last verified
Aug 2025
First submitted
2 Jan 2019
Last updated
18 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Phillips KP, Nair DG, Boersma LVA, Doshi RN, Healey JS, Jaber WA, Mansour M, Reddy VY, Tondo C, Natale A, Sukumar A, Leger K, Christen T, Sutton BS, Wazni OM. Percutaneous left atrial appendage closure following catheter ablation therapy of atrial fibrillation: outcomes stratified by bleeding risk - a sub-analysis of the OPTION study. Europace. 2026 Jun 2;28(6):euag093. doi: 10.1093/europace/euag093.

    PubMed 42225271

  • 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.

    PubMed 39555822

Questions about this trial

What is this clinical trial studying?

A study testing WATCHMAN FLX Implant and Market-approved OAC in people with Atrial Fibrillation, run by Boston Scientific Corporation at 114 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Germany, France, Spain, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism (time frame: From randomization to 1095 days post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03795298, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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