search
Back to results

CHAMPION-AF Clinical Trial (CHAMPION-AF)

Primary Purpose

Atrial Fibrillation, Stroke, Bleeding

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WATCHMAN FLX LAAC Device
Non-Vitamin K Oral Anticoagulant
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • The subject is of legal age to participate in the study per the laws of their respective geography
  • The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
  • The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women
  • The subject is deemed to be suitable for the protocol-defined pharmacologic regimens in both the test and control arms
  • The subject or legal representative is able to understand and 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:

  • Subjects who are currently enrolled in another investigational study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
  • 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 contraindicated or allergic to oral anticoagulation medication and/or aspirin
  • The subject is indicated for chronic P2Y12 platelet inhibitor therapy
  • The subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, etc.)
  • The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment
  • The subject had a prior major bleeding event per ISTH definition within the 30 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 an active bleed
  • The subject has a reversible cause of AF or transient AF
  • The subject is absent of a left atrial appendage (LAA) or the LAA is surgically ligated
  • 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 30 days prior to enrollment
  • The subject has a history of atrial septal repair or has an atrial septal device (ASD)/patent foramen ovale (PFO) device
  • The subject has an implanted mechanical valve prosthesis in any position
  • The subject has a known contraindication to percutaneous catheterization procedure
  • The subject has a known contraindication to transesophageal echo (TEE)
  • The subject has a cardiac tumor
  • The subject has signs/symptoms of acute or chronic pericarditis.
  • The subject has an active infection
  • There is evidence of tamponade physiology
  • The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
  • 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 3 years

Transthoracic Echo Exclusion Criteria:

  • The subject has left ventricular ejection fraction ( LVEF) < 30%
  • The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm
  • The subject has a high-risk PFO with an atrial septal aneurysm excursion > 15mm or length > 15mm
  • The subject has significant mitral valve (MV) stenosis (i.e., MV area <1.5 cm2)

Sites / Locations

  • Grandview Medical Center
  • University of Alabama at Birmingham
  • Arizona Arrhythmia Research Center
  • Phoenix Cardiovascular Research Group
  • Scottsdale Healthcare - Shea
  • Tucson Medical Center Healthcare
  • Arrythmia Research Group
  • Sharp Chula Vista Medical Center
  • Marin General Hospital
  • Scripps Memorial Hospital
  • Los Robles Hospital and Medical Center
  • El Camino Hospital
  • Eisenhower Medical Center
  • Mercy General Hospital
  • Santa Barbara Cottage Hospital
  • St. John's Health Center
  • Colorado Springs Cardiologist, P.C.
  • Yale University School of Medicine
  • Christiana Hospital
  • Washington Hospital Center
  • Manatee Memorial Hospital
  • Bay Area Cardiology Associates, P.A.
  • Broward General Medical Center
  • St. Vincent's Medical Center
  • Lakeland Regional Medical Center
  • Baptist Hospital of Miami
  • AdventHealth Orlando
  • Tallahassee Memorial Hospital
  • Piedmont Hospital
  • Emory University Hospital
  • Memorial Health University Medical Center
  • Northwestern Memorial Hospital
  • Advocate Christ Medical Center
  • St. John's Hospital
  • Franciscan Health Indianapolis
  • Community Hospital
  • Mercy Hospital Medical Center
  • University of Iowa Hospitals and Clinics
  • University of Kansas Hospital
  • Norton Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Lahey Clinic Hospital
  • Charlton Memorial
  • University of Massachusetts Memorial Medical Center
  • Sparrow Health System - Sparrow Hospital
  • William Beaumont Hospital
  • Mercy Hospital
  • Mayo Clinic Foundation
  • Centracare Heart and Vascular Center
  • HealthEast St. Joseph's Hospital
  • North Mississippi Medical Center
  • St. Luke's Hospital of Kansas City
  • Billings Clinic
  • Bergan Cardiology
  • The Nebraska Medical Center
  • Dartmouth Hitchcock Medical Center
  • Catholic Medical Center
  • Englewood Hospital and Medical Center
  • Kaleida Health
  • Mount Sinai Medical Center
  • Columbia University Medical Center
  • Rochester General Hospital
  • St. Francis Hospital
  • Novant Health Presbyterian Medical Center
  • University Hospitals of Cleveland
  • Cleveland Clinic Foundation
  • OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
  • Kettering Medical Center
  • The Toledo Hospital
  • Legacy Emanuel Hospital & Health Center
  • Pinnacle Health at Harrisburg Hospital
  • University of Pittsburgh Medical Center
  • York Hospital
  • Trident Medical Center
  • Medical University of South Carolina
  • Lexington Medical Center
  • Erlanger Medical Center
  • Methodist Le Bonheur Healthcare
  • Centennial Medical Center
  • Vanderbilt University Medical Center
  • Texas Cardiac Arrhythmia Research
  • Heart Hospital of Austin
  • Memorial Hermann Memorial City Medical Center
  • The Heart Hospital Baylor Plano
  • Methodist Texsan Hospital
  • Christus Trinity Mother Frances Health System
  • Inova Fairfax Hospital
  • Virginia Commonwealth University Health System
  • Providence Regional Medical Center Everett
  • Swedish Medical Center
  • CHI Franciscan Health System
  • PeaceHealth Southwest Medical
  • Monongalia General Hospital
  • Aurora St. Luke's Medical Center
  • St. Vincent's Hospital-Sydney
  • Monash Medical Centre
  • Westmead Hospital
  • Onze Lieve Vrouw Ziekenhuis
  • CHU de Charleroi
  • Sunnybrook Health Sciences Centre
  • Institut universitaire de Cardiologie et de Pneumologie de Quebec
  • Aarhus University Hospital
  • Hopital Cardiologique de Lyon
  • CHU Grenoble-Hopital Michallon
  • Hospital de la Pitie-Salpetriere
  • Charite, Campus Benjamin Franklin
  • Klinikum Coburg GmbH
  • Herzzentrum Dresden GmbH
  • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
  • Elisabeth Krankenhaus Essen
  • St. Katharinen Krankenhaus
  • Cardiologicum Hamburg Praxis Wandsbek
  • Universitaetsklinikum Schleswig-Holstein
  • Klinikum der Ludwig-Maximilians-Universitat
  • Shaare Zedek Medical Center
  • Sheba Medical Center
  • Fondazione Toscana Gabriele Monasterio
  • Azienda Ospedaliera Careggi
  • Ospedale Degli Infermi
  • Instituto Clinico Humanitas
  • Chiba University Hospital
  • Kokura Memorial Hospital
  • Iwate Medical University Hospital
  • Mitsui Memorial Hospital
  • Shonan Kamakura General Hospital
  • Kurashiki Central Hospital
  • Toho University Ohashi Medical Center
  • Toyama University Hospital
  • Toyohashi Heart Center
  • University of Tsukuba Hospital
  • St. Antonius Ziekenhuis
  • Poznan University of Medical Sciences
  • King Fahed Medical City- Prince Salman Cardiac Center
  • Hospital Álvaro Cunqueiro
  • Hospital de Leon
  • Hospital Clinico Salamanca
  • University Hospital Zurich
  • Royal Sussex County Hospital
  • Glenfield Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device Group

Control Group

Arm Description

Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device

Randomized to non-vitamin K oral anticoagulant (NOAC)

Outcomes

Primary Outcome Measures

WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism
non-inferiority
WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
superiority
WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism
non-inferiority

Secondary Outcome Measures

The occurrence of ISTH major bleeding
superiority
The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
superiority

Full Information

First Posted
May 14, 2020
Last Updated
October 19, 2023
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT04394546
Brief Title
CHAMPION-AF Clinical Trial
Acronym
CHAMPION-AF
Official Title
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.
Detailed Description
This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device ("Device Group") or a commercially available non-vitamin K oral anticoagulant ("Control Group").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke, Bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device Group
Arm Type
Experimental
Arm Description
Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Randomized to non-vitamin K oral anticoagulant (NOAC)
Intervention Type
Device
Intervention Name(s)
WATCHMAN FLX LAAC Device
Other Intervention Name(s)
WATCHMAN FLX Left Atrial Appendage Closure Device
Intervention Description
WATCHMAN FLX LAAC Device Implantation
Intervention Type
Drug
Intervention Name(s)
Non-Vitamin K Oral Anticoagulant
Other Intervention Name(s)
NOAC
Intervention Description
Initiation or continuation of a NOAC drug
Primary Outcome Measure Information:
Title
WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism
Description
non-inferiority
Time Frame
36-months
Title
WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
Description
superiority
Time Frame
36-months
Title
WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism
Description
non-inferiority
Time Frame
60-months
Secondary Outcome Measure Information:
Title
The occurrence of ISTH major bleeding
Description
superiority
Time Frame
60-months
Title
The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
Description
superiority
Time Frame
60-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 The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women The subject is deemed to be suitable for the protocol-defined pharmacologic regimens in both the test and control arms The subject or legal representative is able to understand and 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: Subjects who are currently enrolled in another investigational study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments 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 contraindicated or allergic to oral anticoagulation medication and/or aspirin The subject is indicated for chronic P2Y12 platelet inhibitor therapy The subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, etc.) The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment The subject had a prior major bleeding event per ISTH definition within the 30 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 an active bleed The subject has a reversible cause of AF or transient AF The subject is absent of a left atrial appendage (LAA) or the LAA is surgically ligated 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 30 days prior to enrollment The subject has a history of atrial septal repair or has an atrial septal device (ASD)/patent foramen ovale (PFO) device The subject has an implanted mechanical valve prosthesis in any position The subject has a known contraindication to percutaneous catheterization procedure The subject has a known contraindication to transesophageal echo (TEE) The subject has a cardiac tumor The subject has signs/symptoms of acute or chronic pericarditis. The subject has an active infection There is evidence of tamponade physiology The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment 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 3 years Transthoracic Echo Exclusion Criteria: The subject has left ventricular ejection fraction ( LVEF) < 30% The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm The subject has a high-risk PFO with an atrial septal aneurysm excursion > 15mm or length > 15mm The subject has significant mitral valve (MV) stenosis (i.e., MV area <1.5 cm2)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marty Leon, MD
Organizational Affiliation
New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kenneth A Ellenbogen, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shephal Doshi, MD
Organizational Affiliation
Pacific Heart Institute and Providence St. John's Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saibal Kar, MD
Organizational Affiliation
HCA Healthhcare /Los Robles Health System
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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-6830
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
85018
Country
United States
Facility Name
Scottsdale Healthcare - Shea
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Tucson Medical Center Healthcare
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arrythmia Research Group
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Sharp Chula Vista Medical Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Marin General Hospital
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Los Robles Hospital and Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
St. John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Colorado Springs Cardiologist, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80932
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
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
34208
Country
United States
Facility Name
Bay Area Cardiology Associates, P.A.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
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
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Franciscan Health Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
14213
Country
United States
Facility Name
Mercy Hospital Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lahey Clinic Hospital
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Charlton Memorial
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Sparrow Health System - Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48013
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Mayo Clinic Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Centracare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
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
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
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
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Bergan Cardiology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14213
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
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
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
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Legacy Emanuel Hospital & Health Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Trident Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Methodist Le Bonheur Healthcare
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7235
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Memorial Hermann Memorial City Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Methodist Texsan Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201-2009
Country
United States
Facility Name
Christus Trinity Mother Frances Health System
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
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
98668
Country
United States
Facility Name
Monongalia General Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
52315
Country
United States
Facility Name
St. Vincent's Hospital-Sydney
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Westmead Hospital
City
Bella Vista
Country
Australia
Facility Name
Onze Lieve Vrouw Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
CHU de Charleroi
City
Charleroi
Country
Belgium
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Institut universitaire de Cardiologie et de Pneumologie de Quebec
City
Québec
Country
Canada
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Hopital Cardiologique de Lyon
City
Bron
Country
France
Facility Name
CHU Grenoble-Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hospital de la Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75151
Country
France
Facility Name
Charite, Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Klinikum Coburg GmbH
City
Coburg
Country
Germany
Facility Name
Herzzentrum Dresden GmbH
City
Dresden
Country
Germany
Facility Name
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
City
Erfurt
Country
Germany
Facility Name
Elisabeth Krankenhaus Essen
City
Essen
Country
Germany
Facility Name
St. Katharinen Krankenhaus
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Cardiologicum Hamburg Praxis Wandsbek
City
Hamburg
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Luebeck
Country
Germany
Facility Name
Klinikum der Ludwig-Maximilians-Universitat
City
München
Country
Germany
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Fondazione Toscana Gabriele Monasterio
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera Careggi
City
Florence
Country
Italy
Facility Name
Ospedale Degli Infermi
City
Rivoli
ZIP/Postal Code
10098
Country
Italy
Facility Name
Instituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba-shi
State/Province
Chiba
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
State/Province
Iwate-ken
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Okamoto
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Okayama
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama-shi
Country
Japan
Facility Name
Toyohashi Heart Center
City
Toyohashi
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
Country
Japan
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Poznan University of Medical Sciences
City
Długa
State/Province
Poznań
Country
Poland
Facility Name
King Fahed Medical City- Prince Salman Cardiac Center
City
Riyadh
Country
Saudi Arabia
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital de Leon
City
Leon
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital Clinico Salamanca
City
Salamanca
Country
Spain
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom

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

CHAMPION-AF Clinical Trial

We'll reach out to this number within 24 hrs