Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

Atrial Fibrillation Clinical Trial

— OPTION  

Official title:

Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03795298
• Other study ID #: S2239
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• WATCHMAN FLX Implant
Left atrial appendage closure with the WATCHMAN FLX device

Drug:
• Market-approved OAC
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Locations

Country	Name	City	State
Australia	Advara HeartCare	Brisbane	Queensland
Australia	Monash Health	Clayton	Victoria
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst	East Flanders
Denmark	Aarhus University Hospital	Aarhus
France	CHRU de Clermont-Ferrand	Clermont-Ferrand
France	CHU Henri Mondor	Créteil	Île-de-France
France	CHU Grenoble - Hopital Michallon	Grenoble
France	CHRU de Lille	Lille	Hauts-de-France
France	Hospital de la Pitie-Salpetriere	Paris	Ile-de-France
France	Hospital Europeen Georges-Pompidou	Paris
France	Centre Hôpital Universitaire Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
Germany	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	Allgemeines Krankenhaus Altona	Hamburg
Germany	Asklepios Klinik Saint Georg	Hamburg
Germany	Klinikum St. Georg	Leipzig
Germany	Universitaetsklinikum Schleswig-Holstein	Lübeck
Germany	St. Josefs-Hospital GmbH	Wiesbaden
Italy	Centro Cardiologico Monzino	Milano
Italy	Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino	Torino
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Poland	Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow	Katowice
Poland	Poznan University of Medical Sciences	Poznan
Poland	Slaskie Centrum Chorob Serca	Zabrze
Spain	Hospital General Universitario	Alicante
Spain	Hospital Puerta Del Mar	Cadiz
Spain	Hospital Clinico San Carlos	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Clinico Salamanca	Salamanca
Spain	Clinico de Valladolid	Valladolid
Spain	Hospital Alvaro Cunqueiro	Vigo
United States	Alaska Regional Hospital	Anchorage	Alaska
United States	Emory University Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	Northwell Health	Bay Shore	New York
United States	HeartPlace Mid-Cities EP	Bedford	Texas
United States	Grandview Medical Center	Birmingham	Alabama
United States	St. Alphonsus Regional Medical Center	Boise	Idaho
United States	St. Lukes Idaho Cardiology Associates	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Mills Peninsula Health Services	Burlingame	California
United States	Lahey Clinic Hospital	Burlington	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Lindner Center for Research and Education at Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Memorial Hospital	Colorado Springs	Colorado
United States	OhioHealth Research and Innovation Institute - Riverside Methodist Hospital	Columbus	Ohio
United States	Iowa Heart Center	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	Pinnacle Health at Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Heart Center Research	Huntsville	Alabama
United States	Methodist Hospital of Indianapolis	Indianapolis	Indiana
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	St. Bernard's Medical Center	Jonesboro	Arkansas
United States	Overland Park Regional Medical Center	Kansas City	Kansas
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Scripps Memorial Hospital	La Jolla	California
United States	Marin General Hospital	Larkspur	California
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Heart Clinic Arkansas	Little Rock	Arkansas
United States	Centura Health	Littleton	Colorado
United States	University of Southern California Hospital	Los Angeles	California
United States	Medical Center of the Rockies (Loveland)	Loveland	Colorado
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	MyMichigan Medical Center Midland	Midland	Michigan
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Monongalia General Hospital	Morgantown	West Virginia
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Intermountain Medical Center	Murray	Utah
United States	Edward Hospital	Naperville	Illinois
United States	Centennial Medical Center	Nashville	Tennessee
United States	Saint Thomas Health	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mount Sinai Medical Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	AdventHealth Ocala	Ocala	Florida
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Kansas City Cardiac Arrhythmia Research	Overland Park	Kansas
United States	Presbyterian University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Arizona Arrhythmia Research Center	Phoenix	Arizona
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Rex Hospital	Raleigh	North Carolina
United States	Chippenham Medical Center	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	Mayo Clinic	Rochester	Minnesota
United States	Mercy Research	Saint Louis	Missouri
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	St. Mark's Hospital	Salt Lake City	Utah
United States	Cardiology Clinic of San Antonio	San Antonio	Texas
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	St. John's Hospital	Springfield	Illinois
United States	CHI Franciscan Health System	Tacoma	Washington
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Los Robles Hospital & Medical Center	Thousand Oaks	California
United States	Christus Trinity Mother Frances Health System	Tyler	Texas
United States	PeaceHealth Southwest Medical	Vancouver	Washington
United States	Washington Hospital Center	Washington	District of Columbia
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke, all cause death, and systemic embolism	WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.	36 months
Primary	Non-procedural bleeding	WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).	36 months
Secondary	Major bleeding	WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).	36 months