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

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WATCHMAN FLX Implant
Market-approved OAC
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Non-valvular atrial fibrillation, Left atrial appendage, Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grandview Medical Center
  • Heart Center Research
  • Alaska Regional Hospital
  • Arizona Arrhythmia Research Center
  • Phoenix Cardiovascular Research Group
  • St. Bernard's Medical Center
  • Heart Clinic Arkansas
  • Mills Peninsula Health Services
  • Scripps Memorial Hospital
  • Marin General Hospital
  • University of Southern California Hospital
  • Sharp Memorial Hospital
  • Kaiser Permanente Santa Clara Medical Center
  • Marian Regional Medical Center
  • Los Robles Hospital & Medical Center
  • Memorial Hospital
  • Centura Health
  • Medical Center of the Rockies (Loveland)
  • Yale University School of Medicine
  • Washington Hospital Center
  • Manatee Memorial Hospital
  • Broward General Medical Center
  • St. Vincent's Medical Center
  • AdventHealth Ocala
  • Tallahassee Memorial Hospital
  • Emory University Hospital
  • Wellstar Kennestone Hospital
  • St. Alphonsus Regional Medical Center
  • St. Lukes Idaho Cardiology Associates
  • Edward Hospital
  • St. John's Hospital
  • Methodist Hospital of Indianapolis
  • St. Vincent Heart Center of Indiana
  • Iowa Heart Center
  • Overland Park Regional Medical Center
  • University of Kansas Hospital
  • Kansas City Cardiac Arrhythmia Research
  • Baptist Health Lexington
  • Massachusetts General Hospital
  • Lahey Clinic Hospital
  • Henry Ford Hospital
  • MyMichigan Medical Center Midland
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • HealthEast St. Joseph's Hospital
  • St. Luke's Hospital of Kansas City
  • Mercy Research
  • Nebraska Heart Institute
  • Catholic Medical Center
  • Cardiovascular Associates of the Delaware Valley
  • Valley Hospital
  • Northwell Health
  • Montefiore Medical Center
  • New York University Medical Center
  • Mount Sinai Medical Center
  • Carolinas Medical Center
  • Duke University Medical Center
  • Rex Hospital
  • Lindner Center for Research and Education at Christ Hospital
  • Cleveland Clinic Foundation
  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
  • Pinnacle Health at Harrisburg Hospital
  • Presbyterian University of Pennsylvania Medical Center
  • University of Pittsburgh Medical Center
  • Lankenau Institute for Medical Research
  • York Hospital
  • Centennial Medical Center
  • Saint Thomas Health
  • Vanderbilt University Medical Center
  • Texas Cardiac Arrhythmia Research
  • HeartPlace Mid-Cities EP
  • The Heart Hospital Baylor Plano
  • Cardiology Clinic of San Antonio
  • Christus Trinity Mother Frances Health System
  • St. Mark's Hospital
  • Chippenham Medical Center
  • CHI Franciscan Health System
  • PeaceHealth Southwest Medical
  • Monongalia General Hospital
  • West Virginia University Hospitals
  • Advara HeartCare
  • Monash Health
  • Onze Lieve Vrouw Ziekenhuis
  • Aarhus University Hospital
  • CHRU de Lille
  • Hospital de la Pitie-Salpetriere
  • CHRU de Clermont-Ferrand
  • CHU Grenoble - Hopital Michallon
  • Hospital Europeen Georges-Pompidou
  • Clinique Pasteur
  • Centre Hôpital Universitaire Rangueil
  • CHU Henri Mondor
  • DHZC - Deutsches Herzzentrum der Charité
  • Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee
  • Klinikum Coburg GmbH
  • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
  • Cardioangiologisches Centrum Bethanien
  • Universitatsklinik Greifswald
  • Asklepios Klinik Saint Georg
  • Allgemeines Krankenhaus Altona
  • Klinikum St. Georg
  • Universitaetsklinikum Schleswig-Holstein
  • St. Josefs-Hospital GmbH
  • Centro Cardiologico Monzino
  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
  • St. Antonius Ziekenhuis
  • Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow
  • University Clinical Hospital in Poznań/ UNIWERSYTECKI SZPITAL KLINICZNY W POZNANIU
  • Slaskie Centrum Chorob Serca
  • Hospital General Universitario
  • Hospital Puerta Del Mar
  • Hospital Clinico San Carlos
  • Clinica Universidad de Navarra
  • Hospital Clinico Salamanca
  • Clinico de Valladolid
  • Hospital Alvaro Cunqueiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WATCHMAN FLX

Market-approved OAC

Arm Description

WATCHMAN FLX implant including modified post-implant drug regimen.

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

Outcomes

Primary Outcome Measures

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.
Non-procedural bleeding
WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).

Secondary Outcome Measures

Major bleeding
WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).

Full Information

First Posted
January 2, 2019
Last Updated
September 22, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03795298
Brief Title
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Acronym
OPTION
Official Title
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Non-valvular atrial fibrillation, Left atrial appendage, Ablation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WATCHMAN FLX
Arm Type
Experimental
Arm Description
WATCHMAN FLX implant including modified post-implant drug regimen.
Arm Title
Market-approved OAC
Arm Type
Active Comparator
Arm Description
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
Intervention Type
Device
Intervention Name(s)
WATCHMAN FLX Implant
Intervention Description
Left atrial appendage closure with the WATCHMAN FLX device
Intervention Type
Drug
Intervention Name(s)
Market-approved OAC
Intervention Description
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
Primary Outcome Measure Information:
Title
Stroke, all cause death, and systemic embolism
Description
WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.
Time Frame
36 months
Title
Non-procedural bleeding
Description
WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Major bleeding
Description
WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oussama Wazni, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Heart Center Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alaska Regional Hospital
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Arrhythmia Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Phoenix Cardiovascular Research Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
St. Bernard's Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Heart Clinic Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mills Peninsula Health Services
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Marin General Hospital
City
Larkspur
State/Province
California
ZIP/Postal Code
94939
Country
United States
Facility Name
University of Southern California Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente Santa Clara Medical Center
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Marian Regional Medical Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Los Robles Hospital & Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Centura Health
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Medical Center of the Rockies (Loveland)
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
AdventHealth Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
St. Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
St. Lukes Idaho Cardiology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Edward Hospital
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Methodist Hospital of Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Overland Park Regional Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas City Cardiac Arrhythmia Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Lahey Clinic Hospital
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
MyMichigan Medical Center Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HealthEast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Northwell Health
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Lindner Center for Research and Education at Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Presbyterian University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
Lankenau Institute for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Saint Thomas Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
HeartPlace Mid-Cities EP
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Cardiology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Christus Trinity Mother Frances Health System
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
St. Mark's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Chippenham Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
CHI Franciscan Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
PeaceHealth Southwest Medical
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Monongalia General Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Advara HeartCare
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120 QLD
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Onze Lieve Vrouw Ziekenhuis
City
Aalst
State/Province
East Flanders
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
CHRU de Lille
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Hospital de la Pitie-Salpetriere
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75013
Country
France
Facility Name
CHRU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU Grenoble - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hospital Europeen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Centre Hôpital Universitaire Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
State/Province
Île-de-France
ZIP/Postal Code
94010
Country
France
Facility Name
DHZC - Deutsches Herzzentrum der Charité
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinikum Coburg GmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
City
Erfurt
ZIP/Postal Code
99097
Country
Germany
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitatsklinik Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Asklepios Klinik Saint Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Allgemeines Krankenhaus Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
4129
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
St. Josefs-Hospital GmbH
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10123
Country
Italy
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow
City
Katowice
ZIP/Postal Code
40635
Country
Poland
Facility Name
University Clinical Hospital in Poznań/ UNIWERSYTECKI SZPITAL KLINICZNY W POZNANIU
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Slaskie Centrum Chorob Serca
City
Zabrze
ZIP/Postal Code
41800
Country
Poland
Facility Name
Hospital General Universitario
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Puerta Del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Clinico de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html

Learn more about this trial

Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

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