Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medinol Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).
This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.
During the study, the patient will undergo the following tests:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valve Medical Dedicated Sheath | Experimental | Valve Medical Dedicated Sheath version 00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valve Medical Dedicated Sheath version 00 | Device | The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Outcome measures will be assessed at 1, 6 and 24 hours post procedure. | |
| Procedure Safety: Adverse Event Assessment for device related and unrelated events | Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mor Buchshtav, M.Sc. | Contact | 972 3 7679000 | 3514 | morb@medinol.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D014694 |
| Ventricular Outflow Obstruction |