- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663375
ACURATE TA™ Valve Implantation Registry: SAVI 2 (TA-SAVI2)
Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Wien, Austria, 1130
- Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
-
-
-
-
-
Augsburg, Germany, 86156
- Klinikum Augsburg
-
Bad Berka, Germany, 99437
- Zentralklinik Bad Berka GmbH
-
Bad Bevensen, Germany, 29459
- Herz- und Gefässzentrum 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 Universitat 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 Nürnberg Süd
-
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
-
-
-
-
-
Massa, Italy, 56126
- U.O.C. cardiochirurgia per adulti- Stabilimento di Massa
-
-
-
-
-
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
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ACURATE TA™ Transapical Aortic Biorposthesis
Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of all-cause mortality at 30 days follow-up
Time Frame: 30-Day 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
Time Frame: 30-Days and 12 Months Follow-up
|
Rate of clinical endpoints (VARC II) at 30 days and 12 months:
|
30-Days and 12 Months Follow-up
|
Procedural success post-implant
Time Frame: Procedure to 24h Post-implantation
|
Procedural success post-implant defined as ACURATE TA™ implanted in intended location with the following criteria:
|
Procedure to 24h Post-implantation
|
Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up
Time Frame: 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:
|
7-Days Follow-up and 12-Months Follow-up
|
Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months
Time Frame: 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.
|
30-Day and 12-Month Follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Walther, Professor, Kerckhoff Klinik
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-04 (Other Identifier: Assistance Publique Hôpitaux de Marseille)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Stenosis
-
Hospices Civils de LyonRecruiting
-
Abbott Medical DevicesActive, not recruitingSevere Aortic Stenosis | Symptomatic Degenerative Aortic StenosisSpain, Italy, United Kingdom, Germany, Switzerland, Czechia, Australia, Belgium, Poland
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
-
Edwards LifesciencesCompletedAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
-
Saint Petersburg State University, RussiaNot yet recruitingIschemic Heart Disease | Mitral Insufficiency | Aortic Stenosis, Severe | Mitral Stenosis | Aortic Insufficiency | Ascending Aortic Aneurysm | Mitral Stenosis With Insufficiency | Tricuspid InsufficiencyRussian Federation
-
Pan XiangbinRecruiting
Clinical Trials on ACURATE TA™ Transapical Aortic Bioprosthesis
-
Symetis SACompletedSymptomatic Aortic StenosisGermany, Italy, Argentina, Switzerland
-
Symetis SACompletedAortic Symptomatic StenosisGermany
-
Symetis SACompletedAortic Stenosis SymptomaticGermany
-
Symetis SATerminated
-
Symetis SACompletedAortic StenosisGermany, Canada, Italy, United Kingdom
-
Symetis SACompletedSymptomatic Aortic StenosisGermany, Japan, Brazil
-
Medico's Hirata Inc.TerminatedSevere Aortic StenosisJapan
-
Symetis SACompletedAortic StenosisGermany, Denmark, Switzerland
-
University of LeipzigNational University of Ireland, GalwayActive, not recruitingAortic StenosisGermany, Switzerland, Sweden, France
-
Symetis SACompleted