Trials / Completed
CompletedNCT03139721
Medtronic HAMMOCK Post Approval Study
Medtronic Hancock II® and Mosaic Mitral and Aortic Valves: A Study to Observe the Effects of the Stent Material Change to PEEK Post Approval Study (HAMMOCK PAS)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 122 (actual)
- Sponsor
- Medtronic Cardiac Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This study is being conducted to satisfy the post-CE approval requirement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mosaic model 305, model 310, and ultra model 305 | Aortic or mitral valve replacement |
Timeline
- Start date
- 2017-06-19
- Primary completion
- 2019-05-17
- Completion
- 2021-06-21
- First posted
- 2017-05-04
- Last updated
- 2024-08-23
- Results posted
- 2024-08-23
Locations
7 sites across 3 countries: United States, Germany, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03139721. Inclusion in this directory is not an endorsement.