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| Name | Class |
|---|---|
| Zentrum für Klinische Studien Leipzig | OTHER |
| University Medical Center Mainz | OTHER |
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To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI | Other | Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy |
|
| TAVI/MitraClip | Experimental | Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral Valve Clipping | Device | Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause and heart failure hospitalization | Composite endpoint of time to heart failure hospitalization or death from any cause | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | Time from randomization to death from any cause | 1, 2, 3, 4 years |
| Need for mitral valve reintervention | Need for mitral valve reintervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with AEs, SAEs. | 1, 2, 3, 4 years |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Linke, MD | Contact | +49 351 4501704 | mitavi@mailbox.tu-dresden.de | |
| Stephan Haussig, MD | Contact | +49 351 4501704 | mitavi@mailbox.tu-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Axel Linke, MD | Technische Universitaet Dresden, HEART CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart-Center Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within five years, if the members of the MITAVI-trial group agree.
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| TAVI | Device | Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy. |
|
| 1, 2, 3, 4 years |
| Mitral regurgitation severity | Mitral regurgitation severity at 12 months | 1 year |
| 6 Minute Walk Test | Change in 6 Minute Walk Test at 12 months | 1 year |
| New York Heart Association Functional Class | Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years | 1, 3, 6 months and 1, 2, 3, 4 years |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D001018 | Aortic Diseases |
| D004194 | Disease |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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