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| ID | Type | Description | Link |
|---|---|---|---|
| 95.02-5660-6278 | Other Identifier | Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) |
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The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACURATE TA™ | Experimental | Patient implanted with ACURATE TA™ Bioprosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACURATE TA™ | 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 Surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from all-cause mortality at 30 day Follow Up | The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery. | 30-Day Follow-up |
| Freedom from all-cause mortality at 12 months Follow Up | The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery. | 12 months Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as; | 2.1 Structural valve deterioration 2.2 Non-structural dysfunction of the implanted study device 2.3 Valve thrombosis, embolism, bleeding event 2.4 Operated valve endocarditis 2.5 Re-intervention on the implanted device 2.6 Valve-related mortality 2.7 Need for new permanent pacemaker or defibrillator within 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Walther, Professor | Kerckhoff Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhoff Klinik GmbH | Bad Nauheim | 61231 | Germany | |||
| Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie |
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| 30-Days and at 12 Months Follow-up |
| Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke. | Defined as cardiovascular death, myocardial infarction and stroke | 30-Day and 12-Month |
| Functional Improvement from baseline | per NYHA functional classification | 30-Days and 12-Month Follow-up |
| Procedural success | defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality. | 24 hours Post-Procedure |
| Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. | Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed: 6.1 Effective orifice area and index (EOA/EOAI) 6.2 Transvalvular Gradients (Peak and mean) 6.3 Paravalvular and intravalvular (Central) leaks 6.4 Aortic Insufficiency 6.5 LV function and hemodynamics 6.6 Valve function and morphology | 30-Day and 12-Month Follow-up |
| Essen |
| 20246 |
| Germany |
| Universitätsklinikum Essen Westdeutsches Herzzentrum Essen | Essen | 45122 | Germany |
| Klinik für Herzchirurgie GmbH | Karlsruhe | 76185 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |