Trials / Active Not Recruiting
Active Not RecruitingNCT04394546
CHAMPION-AF Clinical Trial
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3,000 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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").
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WATCHMAN FLX LAAC Device | WATCHMAN FLX LAAC Device Implantation |
| DRUG | Non-Vitamin K Oral Anticoagulant | Initiation or continuation of a NOAC drug |
Timeline
- Start date
- 2020-10-15
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2020-05-19
- Last updated
- 2026-04-09
Locations
141 sites across 16 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04394546. Inclusion in this directory is not an endorsement.