CHAMPION-AF Clinical Trial (CHAMPION-AF)
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ClinicalTrials.gov Identifier: NCT04394546 |
Recruitment Status :
Active, not recruiting
First Posted : May 19, 2020
Last Update Posted : April 23, 2024
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Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | May 14, 2020 | ||||||||||||
First Posted Date ICMJE | May 19, 2020 | ||||||||||||
Last Update Posted Date | April 23, 2024 | ||||||||||||
Actual Study Start Date ICMJE | October 15, 2020 | ||||||||||||
Estimated Primary Completion Date | December 2027 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | CHAMPION-AF Clinical Trial | ||||||||||||
Official Title ICMJE | WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation | ||||||||||||
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"). | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
Actual Enrollment ICMJE |
3000 | ||||||||||||
Original Enrollment ICMJE | Not Provided | ||||||||||||
Estimated Study Completion Date ICMJE | December 2027 | ||||||||||||
Estimated Primary Completion Date | December 2027 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Transthoracic Echo Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom, United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04394546 | ||||||||||||
Other Study ID Numbers ICMJE | S2437 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Boston Scientific Corporation | ||||||||||||
Original Responsible Party | [Redacted] | ||||||||||||
Current Study Sponsor ICMJE | Boston Scientific Corporation | ||||||||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | Boston Scientific Corporation | ||||||||||||
Verification Date | March 2024 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |