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

May 11, 2012
September 17, 2013
May 2012
March 2014   (final data collection date for primary outcome measure)
all-cause mortality [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01598844 on ClinicalTrials.gov Archive Site
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Not Provided
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Longterm Safety and Performance of the JenaValve
"The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere AoRtic Stenosis

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

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 stenosis
Intervention: Device: Transcatheter aortic valve replacement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
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March 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Petra Hohenadl, Dr. hohenadl@jenavalve.de
Germany,   Netherlands,   Switzerland
 
NCT01598844
JV03PMS
No
JenaValve Technology GmbH
JenaValve Technology GmbH
Not Provided
Principal Investigator: Olaf Wendler, Prof King's College Hospital London
Principal Investigator: Nicolas Doll, Prof Sana Herzchirurgie Stuttgart
JenaValve Technology GmbH
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP