Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2013-11-30
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ACURATE TA™ Transapical Aortic Biorposthesis
Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Symetis SA
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Walther, Professor
Role: PRINCIPAL_INVESTIGATOR
Kerckhoff Klinik
Locations
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Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, , Austria
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 an der Saale, , 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
Herzzentrum Universitätsklinikum Köln
Cologne, , 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 Leipzig GmbH
Leipzig, , Germany
Deutsches Herzzentrum München des Freistaates Bayern
München, , Germany
Klinikum Nürnberg Süd
Nuremberg, , 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, , Germany
U.O.C. cardiochirurgia per adulti- Stabilimento di Massa
Massa, , Italy
Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie
Bern, , Switzerland
Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital
Zurich, , Switzerland
Countries
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Other Identifiers
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2013-04
Identifier Type: -
Identifier Source: org_study_id
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