Trials / Terminated
TerminatedNCT02478008
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CardiAQ TMVI System (Transapical DS) |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2015-06-23
- Last updated
- 2016-03-31
Locations
9 sites across 4 countries: Denmark, France, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02478008. Inclusion in this directory is not an endorsement.