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Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Tricuspid Valve Replacement | Experimental | Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Tricuspid Valve Replacement | Device | Replacement of the tricuspid valve through a transcatheter approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of MAE | Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications. | 30 day post-intervention |
| Investigational Device Success | Device success defined as a reduction in tricuspid regurgitation immediately post-intervention | immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk test | Change in distance (m) compared to baseline assessment | 30 days, 6 months, annual for five years post-intervention |
| Reduction in Tricuspid Regurgitation (TR) Grade | Number of patients presenting with reduction in TR grade compared to baseline assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Gerteis | Contact | +41796015318 | gerteis@tricares.de |
| Name | Affiliation | Role |
|---|---|---|
| Jörg Hausleiter, MD | LMU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Stedelijk Ziekenhuis | Recruiting | Aalst | 9300 | Belgium |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| 30 days, 6 months, annual for five years post-intervention |
| New York Heart Association (NYHA) Function Class | Number of patients presenting with improvement in NYHA classification | 30 days, 6 months, annual for five years post-intervention |
| ZNA Middelheim | Recruiting | Antwerp | Belgium |
|
| UZ Brussel | Recruiting | Brussels | 1090 | Belgium |
|
| Cliniques Universitaires Saint-Luc UCL | Recruiting | Brussels | Belgium |
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| Centre hospitalier universitaire CHU de Liège | Not yet recruiting | Liège | Belgium |
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| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
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| University Medical Center of the Johannes Gutenberg University Mainz | Not yet recruiting | Mainz | 55131 | Germany |
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| Ludwig Maximilian University Hospital | Recruiting | Munich | 81377 | Germany |
|