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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A001113-38 | Other Identifier | 2011-A001113-38 |
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This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).
The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard TAVI procedure | Active Comparator | Patients without Cardiac CT measures before TAVI |
|
| Cardiac CT scan before TAVI procedure | Experimental | patients with cardiac CT measures before TAVI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac computed tomography | Other | cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite end point | Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography | participants will be followed for the duration of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To compare results of transthoracic / transoesophageal echocardiography and cardiac CT | • Size of the aortic annulus/ diameter and area | inclusion visit |
| To compare results of transthoracic / transoesophageal echocardiography and cardiac CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles MD BARONE ROCHETTE | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Grenoble | 38700 | France |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
• Left ventricular outflow tract, anatomy of the aortic roots
| inclusion visit |
| To compare results of transthoracic / transoesophageal echocardiography and cardiac CT | • Left ventricular function, size, volume | inclusion visit |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |