Trials / Completed
CompletedNCT04429646
LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke
A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.
Detailed description
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system, Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and effectiveness of the LAMax device are non-inferior to the Watchman device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous left atrial appendage closure-LAMax | Interventional device, LAMax left atrial appendage closure system |
| DEVICE | Percutaneous left atrial appendage closure-Watchman | Interventional device, Watchman® LAA Closure Device |
Timeline
- Start date
- 2019-04-20
- Primary completion
- 2020-11-11
- Completion
- 2021-06-10
- First posted
- 2020-06-12
- Last updated
- 2022-05-06
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04429646. Inclusion in this directory is not an endorsement.