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.
Study Type
OBSERVATIONAL
Enrollment
250
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.
Rate of all-cause mortality at 30 days follow-up
Rate of all-cause mortality at 30 days follow-up
Time frame: 30-Day Follow-up
Rate of clinical endpoints (VARC II) at 30 days and 12 months
Rate of clinical endpoints (VARC II) at 30 days and 12 months: * Mortality * Stroke * Myocardial infarction * Bleeding complication * Acute kidney injury * Vascular complication * Conduction disturbances and arrhythmia * Other TAVI-related complications
Time frame: 30-Days and 12 Months Follow-up
Procedural success post-implant
Procedural success post-implant defined as ACURATE TA™ implanted in intended location with the following criteria: * Insufficiency \< +3 * Mean aortic gradient \< 20 mmHg * EOA ≥ 1.0 cm2 * No valve-in-valve or conversion to surgery performed
Time frame: 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: * ACURATE TA™ implanted in intended location * No impingement of the mitral valve * Normal coronary blood flow * Valve-in-valve insufficiency \< +3 * Mean gradient \< 20mmHg * EOA ≥ 1.0 cm2 * No valve-in-valve or conversion to surgery performed
Time frame: 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.
Time frame: 30-Day and 12-Month Follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, Austria
Klinikum Augsburg
Augsburg, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany
Kerckhoff-Klinik
Bad Nauheim, Germany
Herz- und Gefäßklinik GmbH
Bad Neustadt an der Saale, Germany
Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie
Bad Oeynhausen, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Germany
Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie
Bochum, Germany
...and 17 more locations