Clinical trial NCT03795298: Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Official title: Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation
Left atrial appendage
Ablation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Stroke, all cause death, and systemic embolism
timeFrame: 36 months
measure: Non-procedural bleeding
timeFrame: 36 months
Secondary outcomes:
measure: Major bleeding
timeFrame: 36 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Anchorage
country: United States
facility: Alaska Regional Hospital
state: Alaska
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Heart Clinic Arkansas
state: Arkansas
city: Burlingame
country: United States
facility: Mills Peninsula Health Services
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Larkspur
country: United States
facility: Marin General Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
city: Santa Maria
country: United States
facility: Marian Regional Medical Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Littleton
country: United States
facility: Centura Health
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies (Loveland)
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Ocala
country: United States
facility: AdventHealth Ocala
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Boise
country: United States
facility: St. Lukes Idaho Cardiology Associates
state: Idaho
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Hospital of Indianapolis
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Midland
country: United States
facility: MyMichigan Medical Center Midland
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Bay Shore
country: United States
facility: Northwell Health
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Bedford
country: United States
facility: HeartPlace Mid-Cities EP
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic of San Antonio
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Richmond
country: United States
facility: Chippenham Medical Center
state: Virginia
city: Tacoma
country: United States
facility: CHI Franciscan Health System
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Brisbane
country: Australia
facility: Advara HeartCare
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
state: East Flanders
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Lille
country: France
facility: CHRU de Lille
state: Hauts-de-France
city: Paris
country: France
facility: Hospital de la Pitie-Salpetriere
state: Ile-de-France
city: Clermont-Ferrand
country: France
facility: CHRU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon
city: Paris
country: France
facility: Hospital Europeen Georges-Pompidou
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Centre Hôpital Universitaire Rangueil
city: Créteil
country: France
facility: CHU Henri Mondor
state: Île-de-France
city: Berlin
country: Germany
facility: DHZC - Deutsches Herzzentrum der Charité
city: Berlin
country: Germany
facility: Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Erfurt
country: Germany
facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Greifswald
country: Germany
facility: Universitatsklinik Greifswald
city: Hamburg
country: Germany
facility: Asklepios Klinik Saint Georg
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Altona
city: Leipzig
country: Germany
facility: Klinikum St. Georg
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital GmbH
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Alicante
country: Spain
facility: Hospital General Universitario
city: Cadiz
country: Spain
facility: Hospital Puerta Del Mar
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Salamanca
country: Spain
facility: Hospital Clinico Salamanca
city: Valladolid
country: Spain
facility: Clinico de Valladolid
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
Study officials:
affiliation: The Cleveland Clinic
name: Oussama Wazni, MD
role: PRINCIPAL_INVESTIGATOR
References: