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The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiovalve TR replacement Group | Experimental | Cardiovalve TR valve replacement System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovalve TR valve replacement System | Device | The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from device or procedure-related adverse events | Freedom from device or procedure-related adverse events | 30 days |
| Reduction in TR grade | Reduction in TR in comparison to baseline | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk test | Change in Six minute walk distance from Baseline | 30 days, 6 months, 12 months, annual for five years |
| KCCQ | Change in health status from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Nickenig, Dr | Bonn Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Bochum | Bad Oeynhausen | 32545 | Germany | |||
| Charité university |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
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prospective, single arm, open label, multi center
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| 30 days, 6 months, 12 months, annual for five years |
| Berlin |
| 10117 |
| Germany |
| Uniklinik Bonn | Bonn | 53127 | Germany |
| Herzzentrum Uniklinik | Cologne | 50937 | Germany |
| Universitäres Herz | Hamburg | 20251 | Germany |
| University Heart Center Lübeck | Lübeck | 20251 | Germany |
| Universitätsklinikum - Regensburg | Regensburg | 93053 | Germany |