Clinical trial NCT02663375: ACURATE TA™ Valve Implantation Registry: SAVI 2
Official title: Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: TAVI
Aortic Stenosis
Transcatheter aortic valve replacement
Transcatheter aortic valve implantation
Transapical Access
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 collect continued surveillance data pertaining to safety and performance of the device.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of all-cause mortality at 30 days follow-up
timeFrame: 30-Day Follow-up
Secondary outcomes:
measure: Rate of clinical endpoints (VARC II) at 30 days and 12 months
timeFrame: 30-Days and 12 Months Follow-up
measure: Procedural success post-implant
timeFrame: Procedure to 24h Post-implantation
measure: Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up
timeFrame: 7-Days Follow-up and 12-Months Follow-up
measure: Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months
timeFrame: 30-Day and 12-Month Follow-up
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Bevensen
country: Germany
facility: Herz- und Gefäßzentrum Bad Bevensen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäßklinik GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Bochum
country: Germany
facility: Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus GmbH
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Essen
country: Germany
facility: Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen
city: Giessen
country: Germany
facility: Justus-Liebig-Universität Gießen
city: Göttingen
country: Germany
facility: Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
city: Karlsruhe
country: Germany
facility: Klinik für Herzchirurgie Karlsruhe GmbH
city: Köln
country: Germany
facility: Herzzentrum Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie
city: Völklingen
country: Germany
facility: SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie
city: Massa
country: Italy
facility: U.O.C. cardiochirurgia per adulti- Stabilimento di Massa
city: Bern
country: Switzerland
facility: Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie
city: Zürich
country: Switzerland
facility: Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital
Study officials:
affiliation: Kerckhoff Klinik
name: Thomas Walther, Professor
role: PRINCIPAL_INVESTIGATOR
References: