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Longterm Safety and Performance of the JenaValve (JUPITER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology GmbH
ClinicalTrials.gov Identifier:
NCT01598844
First received: May 11, 2012
Last updated: September 27, 2016
Last verified: September 2016
  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
Aortic Insufficiency
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 ]

Enrollment: 210
Study Start Date: May 2012
Primary Completion Date: September 2015 (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
High risk patients with aortic insufficiency Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Name: The JenaValve TAVI System

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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

Locations
Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany
University Hospital
Erlangen, Germany
University Heart Centre
Freiburg, Germany
Asklepios Klinik
Hamburg, Germany
Universitäres Herzzentrum Hamburg
Hamburg, Germany
Herzzentrum der Universität
Köln, Germany
Herzzentrum Leipzig - Universitätsklinik
Leipzig, Germany
Deutsches Herzzentrum München
Munich, Germany
Herzzentrum des Städtischen Klinikums München
Munich, Germany
Herz- und Kreislaufzentrum Rotenburg (Fulda)
Rotenburg (Fulda), Germany
Robert Bosch Krankenhaus Stuttgart
Stuttgart, Germany
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Switzerland
Universitätsspital Basel
Basel, Switzerland
Sponsors and Collaborators
JenaValve Technology GmbH
Investigators
Principal Investigator: Olaf Wendler, Prof King's College Hospital, London
Principal Investigator: Hendrik Treede, Prof UKE Hamburg
  More Information

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 27, 2016
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 30, 2016