ACURATE TA™ Valve Implantation Registry: SAVI 2

Aortic Stenosis Clinical Trial

— TA-SAVI2  

Official title:

Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663375
• Other study ID #: 2013-04
• Status: Completed
• First received: December 8, 2014
• Last updated: March 15, 2018
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• ACURATE TA™ Transapical Aortic Bioprosthesis
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.

Locations

Country	Name	City	State
Austria	Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel	Wien
Germany	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
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	Sana-Herzzentrum Cottbus GmbH	Cottbus
Germany	Technische Universität Dresden	Dresden
Germany	Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen	Essen
Germany	Justus-Liebig-Universität Gießen	Giessen
Germany	Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität	Göttingen
Germany	Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie	Hamburg
Germany	Klinik für Herzchirurgie Karlsruhe GmbH	Karlsruhe
Germany	Herzzentrum Universita¨tsklinikum Ko¨ln	Köln
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Deutsches Herzzentrum München des Freistaates Bayern	München
Germany	Klinikum Nürnberg Süd	Nürnberg
Germany	Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie	Regensburg
Germany	SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie	Völklingen
Germany	Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie	Würzburg
Italy	U.O.C. cardiochirurgia per adulti- Stabilimento di Massa	Massa
Switzerland	Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie	Bern
Switzerland	Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause mortality at 30 days follow-up	Rate of all-cause mortality at 30 days follow-up	30-Day Follow-up
Secondary	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	30-Days and 12 Months Follow-up
Secondary	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	Procedure to 24h Post-implantation
Secondary	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	7-Days Follow-up and 12-Months Follow-up
Secondary	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.	30-Day and 12-Month Follow-up