JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
NCT ID: NCT01598844
Last Updated: 2020-11-24
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
210 participants
OBSERVATIONAL
2012-05-30
2018-07-31
Brief Summary
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Detailed Description
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The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High risk patients with aortic stenosis
Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis.
Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
High risk patients with AI
Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation.
Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Interventions
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Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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King's College London
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
JenaValve Technology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Olaf Wendler, Prof
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Hendrik Treede, Prof
Role: PRINCIPAL_INVESTIGATOR
University Heart Center Hamburg
Locations
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Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Herzzentrum der Universität
Cologne, , Germany
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, , Germany
University Hospital
Erlangen, , Germany
University Heart Centre
Freiburg im Breisgau, , Germany
Asklepios Klinik
Hamburg, , Germany
Universitäres Herzzentrum Hamburg
Hamburg, , Germany
Herzzentrum Leipzig - Universitätsklinik
Leipzig, , Germany
Deutsches Herzzentrum München
Munich, , Germany
Herzzentrum des Städtischen Klinikums München
Munich, , Germany
Herz- und Kreislaufzentrum Rotenburg (Fulda)
Rotenburg an der Fulda, , Germany
Robert Bosch Krankenhaus Stuttgart
Stuttgart, , Germany
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Universitätsspital Basel
Basel, , Switzerland
King's College Hospital
London, , United Kingdom
Countries
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References
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Mieres J, Menendez M, Fernandez-Pereira C, Rubio M, Rodriguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol. 2015;2015:458151. doi: 10.1155/2015/458151. Epub 2015 Aug 4.
Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schafer U, Diemert P, Treede H. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13.
Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Ruter F, de Kroon TL, Lange R, Ensminger S, Wendler O. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. Eur J Cardiothorac Surg. 2016 Nov;50(5):874-881. doi: 10.1093/ejcts/ezw170. Epub 2016 May 30.
Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 2018 Jun;91(7):1345-1351. doi: 10.1002/ccd.27370. Epub 2017 Nov 24.
Other Identifiers
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JV03PMS
Identifier Type: -
Identifier Source: org_study_id