Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

NCT ID: NCT03795298

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2024-07-24

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

WATCHMAN FLX

WATCHMAN FLX implant including modified post-implant drug regimen.

Group Type: EXPERIMENTAL

WATCHMAN FLX Implant

Intervention Type: DEVICE

Left atrial appendage closure with the WATCHMAN FLX device

Market-approved OAC

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

Group Type: ACTIVE_COMPARATOR

Market-approved OAC

Intervention Type: DRUG

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

Interventions

WATCHMAN FLX Implant

Left atrial appendage closure with the WATCHMAN FLX device

Intervention Type: DEVICE

Market-approved OAC

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oussama Wazni, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Grandview Medical Center

Birmingham, Alabama, United States

Heart Center Research

Huntsville, Alabama, United States

Alaska Regional Hospital

Anchorage, Alaska, United States

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Heart Clinic Arkansas

Little Rock, Arkansas, United States

Mills Peninsula Health Services

Burlingame, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

Marin General Hospital

Larkspur, California, United States

University of Southern California Hospital

Los Angeles, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

Marian Regional Medical Center

Santa Maria, California, United States

Memorial Hospital

Colorado Springs, Colorado, United States

Centura Health

Littleton, Colorado, United States

Medical Center of the Rockies (Loveland)

Loveland, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Washington Hospital Center

Washington D.C., 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

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

St. Alphonsus Regional Medical Center

Boise, Idaho, United States

St. Lukes Idaho Cardiology Associates

Boise, Idaho, United States

Edward Hospital

Naperville, Illinois, United States

St. John's Hospital

Springfield, Illinois, United States

Methodist Hospital of Indianapolis

Indianapolis, Indiana, United States

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Iowa Heart Center

Des Moines, Iowa, United States

Overland Park Regional Medical Center

Kansas City, Kansas, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Kansas City Cardiac Arrhythmia Research

Overland Park, Kansas, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Lahey Clinic Hospital

Burlington, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

MyMichigan Medical Center Midland

Midland, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Mercy Research

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States

Valley Hospital

Ridgewood, New Jersey, United States

Northwell Health

Bay Shore, New York, United States

New York University Medical Center

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, 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

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, United States

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Centennial Medical Center

Nashville, Tennessee, United States

Saint Thomas Health

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

HeartPlace Mid-Cities EP

Bedford, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Cardiology Clinic of San Antonio

San Antonio, Texas, United States

Christus Trinity Mother Frances Health System

Tyler, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

St. Mark's Hospital

Salt Lake City, Utah, United States

Chippenham Medical Center

Richmond, Virginia, United States

CHI Franciscan Health System

Tacoma, Washington, United States

PeaceHealth Southwest Medical

Vancouver, Washington, United States

Monongalia General Hospital

Morgantown, West Virginia, United States

West Virginia University Hospitals

Morgantown, West Virginia, United States

Advara HeartCare

Brisbane, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Onze Lieve Vrouw Ziekenhuis

Aalst, East Flanders, Belgium

Aarhus University Hospital

Aarhus, , Denmark

CHRU de Lille

Lille, Hauts-de-France, France

CHRU de Clermont-Ferrand

Clermont-Ferrand, , France

CHU Grenoble - Hopital Michallon

Grenoble, , France

Hospital Europeen Georges-Pompidou

Paris, , France

Clinique Pasteur

Toulouse, , France

Centre Hôpital Universitaire Rangueil

Toulouse, , France

CHU Henri Mondor

Créteil, Île-de-France Region, France

Hospital de la Pitie-Salpetriere

Paris, Île-de-France Region, France

DHZC - Deutsches Herzzentrum der Charité

Berlin, , Germany

Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee

Berlin, , Germany

Klinikum Coburg GmbH

Coburg, , Germany

St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

Erfurt, , Germany

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Universitatsklinik Greifswald

Greifswald, , Germany

Asklepios Klinik Saint Georg

Hamburg, , Germany

Allgemeines Krankenhaus Altona

Hamburg, , Germany

Klinikum St. Georg

Leipzig, , Germany

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

St. Josefs-Hospital GmbH

Wiesbaden, , Germany

Centro Cardiologico Monzino

Milan, , Italy

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

Torino, , Italy

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Poznan University of Medical Sciences

Poznan, , Poland

Hospital General Universitario

Alicante, , Spain

Hospital Puerta Del Mar

Cadiz, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Clinico Salamanca

Salamanca, , Spain

Clinico de Valladolid

Valladolid, , Spain

Hospital Alvaro Cunqueiro

Vigo, , Spain

Countries

United States; Australia; Belgium; Denmark; France; Germany; Italy; Netherlands; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 39555822 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

S2239

Identifier Type: -

Identifier Source: org_study_id