Clinical trial NCT03143686: ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Aortic Stenosis
Keywords: Severe symptomatic Aortic Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-08
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 registry includes all comer patients 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 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.

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 major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
timeFrame: 30 days and 12 Months Follow-up
Secondary outcomes:
measure: Procedural Success post-implantation (up to 24 hours after device implantation)
timeFrame: Post-Implantation (up to 24 hours after device implantation)
measure: Device success at 30 days and 12 Months follow-up
timeFrame: 30 days and 12 Months follow-up
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Aachen
country: Germany
facility: RWTH Aachen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik Bad Nauheim
city: Bad Neustadt
country: Germany
facility: Herz-und Gefäss-Klinik GmbH
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller'sche Kliniken GmbH
city: Dresden
country: Germany
facility: Herzzentrum Dresden Universitätsklinik
city: Essen
country: Germany
facility: Klinik für Tgorax und Gefässchirurgie
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum
city: Karlsruhe
country: Germany
facility: Klinik für Herzchirurgie
city: Köln
country: Germany
facility: Uniklinik Köln Herzzentrum
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Mainz
country: Germany
facility: Universitäts Medizin Mainz
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Sana Herzchirurgie Stuttgart GmbH
city: Bologna
country: Italy
facility: Policlinico s. Orsola-Malpighi
city: Bern
country: Switzerland
facility: Inselspital-Stiftung
Study officials:
References: