Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stdy never submitted to any regulatory body or never initiated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MV replacement with Innovalve TMVR system | Experimental | MV replacement with Innovalve TMVR system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovalve TMVR system | Device | Innovalve TMVR system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with implant or delivery related serious adverse events at 30 days | Number of patients with implant or delivery related serious adverse events at 30 days | 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided