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

May 11, 2012
September 27, 2016
May 2012
September 2015   (Final data collection date for primary outcome measure)
all-cause mortality [ Time Frame: 30 day ]
Same as current
Complete list of historical versions of study NCT01598844 on ClinicalTrials.gov Archive Site
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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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with severe aortic stenosis or with severe aortic insufficiency and an increased risk for an open aortic valve replacement surgery
  • Aortic Stenosis
  • Aortic Insufficiency
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
  • High risk patients with aortic insufficiency
    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.
 
Active, not recruiting
210
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September 2015   (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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   Switzerland
 
 
NCT01598844
JV03PMS
No
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JenaValve Technology GmbH
JenaValve Technology GmbH
Not Provided
Principal Investigator: Olaf Wendler, Prof King's College Hospital, London
Principal Investigator: Hendrik Treede, Prof UKE Hamburg
JenaValve Technology GmbH
September 2016

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