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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 provide safety surveillance of the device.
A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating 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 Bioprosthesis | The first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted. |
|
| 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 major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant | Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant . MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke. | 30 days and 12 Months Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success post-implantation (up to 24 hours after device implantation) | Procedural success defined as successful ACURATE TA™ implantation at intended site and adequate device functioning immediately post-implantation and without intra-procedural mortality | Post-Implantation (up to 24 hours after device implantation) |
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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 registry includes all comer patients following the Instructions For Use.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | 4190 | Argentina | |||
| RWTH Aachen |
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| Device success at 30 days and 12 Months follow-up |
Device success at 30 day and 12 month follow-up visit defined as adequate functioning of the ACURATE TA™ as confirmed by echocardiography. |
| 30 days and 12 Months follow-up |
| Aachen |
| 52074 |
| Germany |
| Zentralklinik Bad Berka | Bad Berka | 99437 | Germany |
| Kerckhoff Klinik Bad Nauheim | Bad Nauheim | 61231 | Germany |
| Herz-und Gefäss-Klinik GmbH | Bad Neustadt an der Saale | 97616 | Germany |
| Schüchtermann-Schiller'sche Kliniken GmbH | Bad Rothenfelde | 49214 | Germany |
| Uniklinik Köln Herzzentrum | Cologne | 50937 | Germany |
| Herzzentrum Dresden Universitätsklinik | Dresden | 01307 | Germany |
| Klinik für Tgorax und Gefässchirurgie | Essen | 45122 | Germany |
| Universitäres Herzzentrum | Hamburg | 20251 | Germany |
| Klinik für Herzchirurgie | Karlsruhe | 76185 | Germany |
| Herzzentrum Leipzig | Leipzig | 04289 | Germany |
| Universitäts Medizin Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Sana Herzchirurgie Stuttgart GmbH | Stuttgart | 70174 | Germany |
| Policlinico s. Orsola-Malpighi | Bologna | 40138 | Italy |
| Inselspital-Stiftung | Bern | 3010 | Switzerland |