Clinical trial NCT01598844: JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
Official title: The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Aortic Insufficiency
Aortic Regurgitation
Lead sponsor: JenaValve Technology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: King's College London
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2012-05-15
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe aortic stenosis or with severe aortic insufficiency and an increased risk for an open aortic valve replacement surgery

Brief summary: The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.

Detailed description: The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement.

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.

Eligibility criteria: Inclusion Criteria:

* Patients suitable for TAVI with the JenaValve according to instructions for use

Exclusion Criteria:

* Patients unsuitable for TAVI with the JenaValve according to instructions for use

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 day
Secondary outcomes:
measure: Safety Endpoints
timeFrame: peri- and post-operatively and at 3, 6, 12, 24 and 36 months
measure: Device Success
timeFrame: Index Procedure and Immediate Post-operative
measure: Device Effectiveness
timeFrame: Prior to discharge, at 3, 6, 12, 24 and 36 months
measure: SF-12 Survey of Quality of Life
timeFrame: at 12 months
measure: Combined Safety Endpoint
timeFrame: at 30 days
measure: Combined Efficacy Endpoint
timeFrame: at 12 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Dresden
country: Germany
facility: Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
city: Erlangen
country: Germany
facility: University Hospital
city: Freiburg
country: Germany
facility: University Heart Centre
city: Hamburg
country: Germany
facility: Asklepios Klinik
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Köln
country: Germany
facility: Herzzentrum der Universität
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig - Universitätsklinik
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Munich
country: Germany
facility: Herzzentrum des Städtischen Klinikums München
city: Rotenburg An Der Fulda
country: Germany
facility: Herz- und Kreislaufzentrum Rotenburg (Fulda)
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus Stuttgart
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College Hospital NHS Trust
name: Olaf Wendler, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart Center Hamburg
name: Hendrik Treede, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.