ACURATE TA™ Valve Implantation Registry: SAVI 2

Completed

• Conditions: Aortic Stenosis
• Interventions: Device: ACURATE TA™ Transapical Aortic Bioprosthesis

• Registration Number: NCT02663375
• Lead Sponsor: Symetis SA

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-12-08
• Primary Completion: 2015-01
• Study Completion: 2016-01
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACURATE TA™ Transapical Aortic Biorposthesis	ACURATE TA™ Transapical Aortic Bioprosthesis	Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System

Primary Outcome Measures

Name	Time	Method
Rate of all-cause mortality at 30 days follow-up	30-Day Follow-up	Rate of all-cause mortality at 30 days follow-up

Secondary Outcome Measures

Name	Time	Method
Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up	7-Days Follow-up and 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
Rate of clinical endpoints (VARC II) at 30 days and 12 months	30-Days and 12 Months Follow-up	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
Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months	30-Day and 12-Month Follow-up	Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up.
Procedural success post-implant	Procedure to 24h Post-implantation	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

Trial Locations

Locations (27)

Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel; 🇦🇹 Wien, Austria

Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie; 🇨🇭 Bern, Switzerland

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Herz- und Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

Herz- und Gefäßklinik GmbH; 🇩🇪 Bad Neustadt, Germany

Immanuel Klinikum Bernau Herzzentrum Brandenburg; 🇩🇪 Bernau, Germany

Klinik für Herzchirurgie Karlsruhe GmbH; 🇩🇪 Karlsruhe, Germany

Herzzentrum Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

U.O.C. cardiochirurgia per adulti- Stabilimento di Massa; 🇮🇹 Massa, Italy

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Sana-Herzzentrum Cottbus GmbH; 🇩🇪 Cottbus, Germany

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 München, Germany

Technische Universität Dresden; 🇩🇪 Dresden, Germany

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität; 🇩🇪 Göttingen, Germany

Klinikum Nürnberg Süd; 🇩🇪 Nürnberg, Germany

Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital; 🇨🇭 Zürich, Switzerland

Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie; 🇩🇪 Hamburg, Germany

SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie; 🇩🇪 Völklingen, Germany

Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie; 🇩🇪 Würzburg, Germany

Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie; 🇩🇪 Bochum, Germany

Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen; 🇩🇪 Essen, Germany

Justus-Liebig-Universität Gießen; 🇩🇪 Giessen, Germany

Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie; 🇩🇪 Regensburg, Germany