ACURATE TA™ Valve Implantation Registry: SAVI 2 (TA-SAVI2)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: ACURATE TA™ Transapical Aortic Bioprosthesis

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1130
    • Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Bad Bevensen, Germany, 29459
    • Herz- und Gefasszentrum Bad Bevensen
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik
  • Bad Neustadt, Germany, 97616
    • Herz- und Gefäßklinik GmbH
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Bernau, Germany, 16321
    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Bochum, Germany, 44801
    • Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie
  • Cottbus, Germany, 03048
    • Sana-Herzzentrum Cottbus GmbH
  • Dresden, Germany, 01062
    • Technische Universität Dresden
  • Essen, Germany, 45122
    • Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen
  • Giessen, Germany, 35392
    • Justus-Liebig-Universität Gießen
  • Göttingen, Germany, 37075
    • Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
  • Karlsruhe, Germany, 76185
    • Klinik für Herzchirurgie Karlsruhe GmbH
  • Köln, Germany, 50937
    • Herzzentrum Universitätsklinikum Köln
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • München, Germany, 80636
    • Deutsches Herzzentrum München des Freistaates Bayern
  • Nürnberg, Germany, 90471
    • Klinikum Nurnberg Sud
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie
  • Völklingen, Germany, 66333
    • SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie
• Italy
  • Massa, Italy, 56126
    • U.O.C. cardiochirurgia per adulti- Stabilimento di Massa
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie
  • Zürich, Switzerland, 8091
    • Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACURATE TA™ Transapical Aortic Biorposthesis; Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System	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.; Other Names: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Thomas Walther, Professor, Kerckhoff Klinik

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Aortic Stenosis; TAVI; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; Transapical Access
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2013-04 (Assistance Publique Hôpitaux de Marseille)