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Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™.
The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open surgery is considered to be associated with high surgical risk.
The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACURATE TA™ Transapical Aortic Biorposthesis | Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACURATE TA™ Transapical Aortic Bioprosthesis | Device | ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause mortality at 30 days follow-up | Rate of all-cause mortality at 30 days follow-up | 30-Day Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical endpoints (VARC II) at 30 days and 12 months | Rate of clinical endpoints (VARC II) at 30 days and 12 months:
| 30-Days and 12 Months Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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ACURATE TA™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the Instructions For Use.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Walther, Professor | Kerckhoff Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel | Vienna | 1130 | Austria | |||
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|
| Procedural success post-implant | Procedural success post-implant defined as ACURATE TA™ implanted in intended location with the following criteria:
| Procedure to 24h Post-implantation |
| Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up | Device success analyzed by ECHO measurement at 7 days or discharge (whichever occurs first) and at 12 months follow-up and defined as the following criteria:
| 7-Days Follow-up and 12-Months Follow-up |
| Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months | Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up. | 30-Day and 12-Month Follow-up |
| Klinikum Augsburg |
| Augsburg |
| 86156 |
| Germany |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany |
| Herz- und Gefäßzentrum Bad Bevensen | Bad Bevensen | 29459 | Germany |
| Kerckhoff-Klinik | Bad Nauheim | 61231 | Germany |
| Herz- und Gefäßklinik GmbH | Bad Neustadt an der Saale | 97616 | Germany |
| Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie | Bad Oeynhausen | 32545 | Germany |
| Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Immanuel Klinikum Bernau Herzzentrum Brandenburg | Bernau | 16321 | Germany |
| Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie | Bochum | 44801 | Germany |
| Herzzentrum Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Sana-Herzzentrum Cottbus GmbH | Cottbus | 03048 | Germany |
| Technische Universität Dresden | Dresden | 01062 | Germany |
| Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen | Essen | 45122 | Germany |
| Justus-Liebig-Universität Gießen | Giessen | 35392 | Germany |
| Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität | Göttingen | 37075 | Germany |
| Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie | Hamburg | 20246 | Germany |
| Klinik für Herzchirurgie Karlsruhe GmbH | Karlsruhe | 76185 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Deutsches Herzzentrum München des Freistaates Bayern | München | 80636 | Germany |
| Klinikum Nürnberg Süd | Nuremberg | 90471 | Germany |
| Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie | Regensburg | 93053 | Germany |
| SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie | Völklingen | 66333 | Germany |
| Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie | Würzburg | 97080 | Germany |
| U.O.C. cardiochirurgia per adulti- Stabilimento di Massa | Massa | 56126 | Italy |
| Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie | Bern | 3010 | Switzerland |
| Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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