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The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Tricuspid Valve Repair | Device | Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | Reduction in severity of Tricuspid Regurgitation at discharge. | Hospital discharge, 2-7 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event Rate | Rates of major adverse | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
| Procedure Success | Reduction in severity of Tricuspid Regurgitation (TR) severity |
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Inclusion Criteria:
Exclusion Criteria:
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Symptomatic patients with chronic functional tricuspid regurgitation (FTR)
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| Name | Affiliation | Role |
|---|---|---|
| Georg Nickenig, MD | Universitätsklinikum Bonn, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulm University | Ulm | Bavaria | 89081 | Germany | ||
| Universitätsklinik der Ruhr-Universität Bochum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35576863 | Derived | Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13. |
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| 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
| Change in Quality of Life - KCCQ | Improvement in Quality of Life as assessed by KCCQ. | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
| Change in Quality of Life - EQ-5D-5L | Improvement in Quality of Life as assessed by EQ-5D-5L | 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
| Bad Oeynhausen |
| North Rhine-Westphalia |
| 32545 |
| Germany |
| Herzzentrum der UniKlinik Köln | Cologne | North Rhine-Westphalia | 50924 | Germany |
| Charité - Universitätsmedizin Campus Mitte | Berlin | 10117 | Germany |
| Berlin Charité-Benjamin Franklin | Berlin | 12203 | Germany |
| Universitätsklinikum Bonn | Bonn | 51312 | Germany |
| Herzzentrum Universitätsklinik Dresden | Dresden | 01307 | Germany |
| University Hospital Erlangen | Erlangen | 91054 | Germany |
| Universitätsmedizin Göttingen, Herzzentrum Göttingen | Göttingen | 37075 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| UKE Hamburg | Hamburg | 20246 | Germany |
| Katholisches Marienkrankenhaus | Hamburg | 22087 | Germany |
| Hospital Universitario Ramón y Cahal | Madrid | 28034 | Spain |
| Universitätsspital Bern (Inselspital) | Bern | 3010 | Switzerland |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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