ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
- Conditions
- Symptomatic Aortic Stenosis
- Interventions
- Device: ACURATE TA™ Transapical Aortic Bioprosthesis
- Registration Number
- NCT03143686
- Lead Sponsor
- Symetis SA
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Patient has severe aortic stenosis
- Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
- Patient willing to participate in the study and provides signed EC-approved informed consent
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
- Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ACURATE TA™ Transapical Aortic Bioprosthesis 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.
- Primary Outcome Measures
Name Time Method Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant 30 days and 12 Months Follow-up 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.
- Secondary Outcome Measures
Name Time Method Device success at 30 days and 12 Months follow-up 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.
Procedural Success post-implantation (up to 24 hours after device implantation) 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
Trial Locations
- Locations (17)
RWTH Aachen
🇩🇪Aachen, Germany
Herz-und Gefäss-Klinik GmbH
🇩🇪Bad Neustadt, Germany
Zentralklinik Bad Berka
🇩🇪Bad Berka, Germany
Kerckhoff Klinik Bad Nauheim
🇩🇪Bad Nauheim, Germany
Herzzentrum Dresden Universitätsklinik
🇩🇪Dresden, Germany
Schüchtermann-Schiller'sche Kliniken GmbH
🇩🇪Bad Rothenfelde, Germany
Klinik für Herzchirurgie
🇩🇪Karlsruhe, Germany
Klinik für Tgorax und Gefässchirurgie
🇩🇪Essen, Germany
Universitäres Herzzentrum
🇩🇪Hamburg, Germany
Universitäts Medizin Mainz
🇩🇪Mainz, Germany
Uniklinik Köln Herzzentrum
🇩🇪Köln, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
Sana Herzchirurgie Stuttgart GmbH
🇩🇪Stuttgart, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Policlinico s. Orsola-Malpighi
🇮🇹Bologna, Italy
Inselspital-Stiftung
🇨🇭Bern, Switzerland
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina