Longterm Safety and Performance of the JenaValve (JUPITER)

This study is currently recruiting participants.
Verified September 2013 by JenaValve Technology GmbH
Information provided by (Responsible Party):
JenaValve Technology GmbH
ClinicalTrials.gov Identifier:
First received: May 11, 2012
Last updated: September 17, 2013
Last verified: September 2013

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

Condition Intervention
Aortic Stenosis
Device: Transcatheter aortic valve replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: "The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere AoRtic Stenosis

Resource links provided by NLM:

Further study details as provided by JenaValve Technology GmbH:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
High risk patients with aortic stenosis Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Name: The JenaValve TAVI System


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with severe aortic stenosis and an increased risk for an open aortic valve replacement surgery


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598844

Contact: Petra Hohenadl, Dr. hohenadl@jenavalve.de

Herz- und Diabeteszentrum NRW Recruiting
Bad Oeynhausen, Germany
Principal Investigator: S. Ensminger, Prof. Dr. med.         
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden Recruiting
Dresden, Germany
Principal Investigator: U. Kappert, PD Dr. med.         
University Hospital Recruiting
Erlangen, Germany
Principal Investigator: R. Feyrer, PD Dr. med.         
University Heart Centre Recruiting
Freiburg, Germany
Principal Investigator: F. Beyersdorf, Prof. Dr.Dr.         
Universitäres Herzzentrum Hamburg Recruiting
Hamburg, Germany
Principal Investigator: H. Treede, PD Dr. med.         
Herzzentrum Leipzig - Universitätsklinik Recruiting
Leipzig, Germany
Principal Investigator: D. Holzhey, Dr. med.         
Herzzentrum des Städtischen Klinikums München Recruiting
Munich, Germany
Principal Investigator: W. Eichinger, PD Dr. med.         
Deutsches Herzzentrum München Recruiting
Munich, Germany
Principal Investigator: R. Lange, Prof. Dr. med.         
Herz- und Kreislaufzentrum Rotenburg (Fulda) Recruiting
Rotenburg (Fulda), Germany
Principal Investigator: A. Rastan, PD Dr. med.         
Robert Bosch Krankenhaus Stuttgart Recruiting
Stuttgart, Germany
Principal Investigator: U. Franke, PD Dr. med.         
Sub-Investigator: H. Baumbach, Dr. med.         
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Principal Investigator: Thom De Kroon, Dr.med.         
Universitätsspital Basel Recruiting
Basel, Switzerland
Principal Investigator: F. Rüter, Dr. med.         
Sponsors and Collaborators
JenaValve Technology GmbH
Principal Investigator: Olaf Wendler, Prof King's College Hospital London
Principal Investigator: Nicolas Doll, Prof Sana Herzchirurgie Stuttgart
  More Information

No publications provided

Responsible Party: JenaValve Technology GmbH
ClinicalTrials.gov Identifier: NCT01598844     History of Changes
Other Study ID Numbers: JV03PMS
Study First Received: May 11, 2012
Last Updated: September 17, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 23, 2014