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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitral valve repair including the use of force feedback instruments | Experimental | Patients with moderate-severe or severe mitral regurgitation resulting from primary (degenerative) etiology who are candidates for robotic-assisted mitral valve repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral Valve Repair including the use of Force Feedback instruments | Device | Robotic-assisted mitral valve repair including the use of Force Feedback instruments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events | The primary safety endpoint will be evaluated by the incidence of major (Clavien-Dindo Grade III or higher) adverse events related to the use of Force Feedback instruments during robotic-assisted mitral valve repair. | 30 days postoperative |
| Residual Mitral Regurgitation Grade on a Transthoracic Echocardiogram (TTE) | The primary effectiveness endpoint will be evaluated as residual mitral regurgitation of moderate (Grade 2) or less measured by an echocardiogram after robotic-assisted mitral valve repair. | Postoperative Day 2-7 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
PREOPERATIVE EXCLUSION CRITERIA:
INTRAOPERATIVE EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer McCrea | Contact | 303-956-0363 | jennifer.mccrea@intusurg.com | |
| Manish Bharara | Contact | manish.bharara@intusurg.com |
Not provided
Not provided
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