ACURATE TA™ Valve Implantation Registry: SAVI 2

NCT02663375 | Completed

• 1 other identifier: 2013-04
• Study Type: observational
• Target: 250
• Locations: 4 countries
• Sites: 27

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.

Conditions

Aortic Stenosis

Keywords

TAVI; Aortic Stenosis; Transcatheter aortic valve replacement; Transcatheter aortic valve implantation; Transapical Access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of clinical endpoints (VARC II) at 30 days and 12 months

  30-Days and 12 Months Follow-up

• Procedural success post-implant

  Procedure to 24h Post-implantation

• 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

• Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months

  30-Day and 12-Month Follow-up

Study Arms (1)

ACURATE TA™ Transapical Aortic Biorposthesis

Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System

Device: ACURATE TA™ Transapical Aortic Bioprosthesis

Interventions

ACURATE TA™ Transapical Aortic Bioprosthesis DEVICE

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.

Also known as: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System

ACURATE TA™ Transapical Aortic Biorposthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Symetis SA: lead

Study Sites (27)

Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

Vienna, 1130, Austria

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, 29459, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Herz- und Gefäßklinik GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie

Bochum, 44801, Germany

Location

Herzzentrum Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Sana-Herzzentrum Cottbus GmbH

Cottbus, 03048, Germany

Location

Technische Universität Dresden

Dresden, 01062, Germany

Location

Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen

Essen, 45122, Germany

Location

Justus-Liebig-Universität Gießen

Giessen, 35392, Germany

Location

Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität

Göttingen, 37075, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie

Hamburg, 20246, Germany

Location

Klinik für Herzchirurgie Karlsruhe GmbH

Karlsruhe, 76185, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, 80636, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie

Regensburg, 93053, Germany

Location

SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie

Völklingen, 66333, Germany

Location

Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie

Würzburg, 97080, Germany

Location

U.O.C. cardiochirurgia per adulti- Stabilimento di Massa

Massa, 56126, Italy

Location

Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie

Bern, 3010, Switzerland

Location

Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Thomas Walther, Professor

  Kerckhoff Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: January 26, 2016
• Study Start: November 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

CH (2); IT (1); DE (23); AU (1)