Trials / Completed
CompletedNCT03039855
Tiara™ Transcatheter Mitral Valve Replacement Study
Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 157 (actual)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed description
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TIARA valve and transapical delivery system | Transcatheter mitral valve replacement |
Timeline
- Start date
- 2017-03-08
- Primary completion
- 2019-12-19
- Completion
- 2024-08-06
- First posted
- 2017-02-01
- Last updated
- 2025-09-29
Locations
20 sites across 6 countries: Germany, Israel, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03039855. Inclusion in this directory is not an endorsement.