Longterm Safety and Performance of the JenaValve (JUPITER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by JenaValve Technology GmbH
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology GmbH
ClinicalTrials.gov Identifier:
NCT01598844
First received: May 11, 2012
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
Germany
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.         
Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Principal Investigator: Thom De Kroon, Dr.med.         
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland
Principal Investigator: F. Rüter, Dr. med.         
Sponsors and Collaborators
JenaValve Technology GmbH
Investigators
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:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on October 16, 2014