Trials / Completed
CompletedNCT01118299
AMPLATZER Cardiac Plug Clinical Trial
Amplatzer Cardiac Plug Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMPLATZER Cardiac Plug | AMPLATZER Cardiac Plug is a percutaneous transcatheter device |
Timeline
- Start date
- 2010-04-26
- Primary completion
- 2018-12-06
- Completion
- 2018-12-06
- First posted
- 2010-05-06
- Last updated
- 2020-04-14
- Results posted
- 2020-04-14
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01118299. Inclusion in this directory is not an endorsement.