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This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.
The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Device | The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve. | ||
| Edwards PASCAL Precision Transcatheter Valve Repair System | Device | The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with major adverse events (MAE rates) | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days | 30 days |
| Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography | Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval. | Discharge: defined as discharge or 7 days post-procedure, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Volume overload assessed by serial measurements | Patient edema questionnaire | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Volume overload assessed by serial measurements | Body weight in kilogram |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient tricuspid valve (TR ≥ 3+) by a Heart Team who assesses patient risk and anatomic suitability for the procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Baldus, Prof. Dr. | Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie | Tübingen | Baden-Wurttemberg | 72076 | Germany | ||
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| baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Volume overload assessed by serial measurements | Edema Assessment (scale 1+ - 4+) grade correspond to mm | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Volume overload assessed by serial measurements | Ankle circumference measurement in cm | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Functional class, functional status, and Quality of life as assessed | NYHA classification (I-IV) grade | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Functional class, functional status, and Quality of life as assessed | 6-Minute Walk Test in meter | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Functional class, functional status, and Quality of life as assessed | 5 Level EQ 5D Questionnaire | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Functional class, functional status, and Quality of life as assessed | Kansas City Cardiomyopathy Questionnaire | baseline, 30 days, 6 months, 12 months, annually up to 5 years |
| Universitätsklinikum Ulm Innere Medizin II |
| Ulm |
| Baden-Wurttemberg |
| 89070 |
| Germany |
| Medizinische Klinik I- Campus Grosshadern | München | Bavaria | 81377 | Germany |
| Herzzentrum Universitätsklinikum Köln | Cologne | DEU | D-50937 | Germany |
| Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie | Essen | Nordrhine Westfalia | 45147 | Germany |
| Herz- und Diabeteszentrum NRW - Bad Oeynhausen | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| Herzzentrum der Universitätsklinik Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Heart Centre of the University Leipzig | Leipzig | Saxony | 04289 | Germany |
| Zentralklinik Bad Berka GmbH | Bad Berka | Thuringia | 99437 | Germany |
| UKE Hamburg | Hamburg | 20246 | Germany |
| Kath. Marienkrankenhaus Hamburg gGmbH | Hamburg | 22087 | Germany |
| University Heart Center Lübeck | Lübeck | Germany |
| Hygeia Hospital | Athens | 151 23 | Greece |
| Ospedale del Cuore "G. Pasquinucci" | Massa | Italy |
| 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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