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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
| European Cardiovascular Research Center | NETWORK |
| University of British Columbia | OTHER |
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The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards CENTERA Self-Expanding Transcatheter Heart Valve | Device | The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR). |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality rate | 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Windecker, MD | Inselspital Bern (Switzerland) | Principal Investigator |
| Prof. Hermann Reichenspurner, MD | University Heart Center Hamburg (Germany) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Brisbane | Queensland | 4032 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30947942 | Derived | Tchetche D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Sondergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231. | |
| 29268926 |
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|
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Epworth Healthcare | Melbourne | Victoria | 3121 | Australia |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Institut Hospitalier Jacques Cartier | Massy | 91300 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| Clinique Pasteur | Toulouse | 31300 | France |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Charité - Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| Herzzentrum Universitaet Bonn | Bonn | 53105 | Germany |
| Asklepios Klinik St Georg | Hamburg | 20099 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH | Karlsruhe | 76133 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| LMU - Klinikum der Universitaet Muenchen | Munich | 81377 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania | Catania | 95124 | Italy |
| Ospedale San Raffaele s.r.l. | Milan | 20132 | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | 56124 | Italy |
| Academisch Medisch Centrum (AMC) | Amsterdam | 1105 | Netherlands |
| Erasmus University Medical Center Rotterdam | Rotterdam | 3015 | Netherlands |
| Universitair Medical Center (UMC) Utrecht | Utrecht | 3584 | Netherlands |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| Reichenspurner H, Schaefer A, Schafer U, Tchetche D, Linke A, Spence MS, Sondergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060. |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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