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Longterm Safety and Performance of the JenaValve (JUPITER)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598844
First Posted: May 15, 2012
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JenaValve Technology GmbH
May 11, 2012
May 15, 2012
July 11, 2017
May 2012
September 2015   (Final data collection date for primary outcome measure)
all-cause mortality [ Time Frame: 30 day ]
30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve prosthesis irrespective of the underlying cause of death.
all-cause mortality [ Time Frame: 30 day ]
Complete list of historical versions of study NCT01598844 on ClinicalTrials.gov Archive Site
  • Safety Endpoints [ Time Frame: peri- and post-operatively and at 3, 6, 12, 24 and 36 months ]
    • All-cause mortality,
    • Cardiovascular mortality,
    • Major stroke,
    • Life-threatening or disabling bleeding,
    • Major bleeding,
    • Acute kidney injury,
    • Myocardial infarction,
    • Major vascular complication,
    • Mechanical coronary obstruction,
    • Prosthetic valve thrombus,
    • Prosthetic valve endocarditis,
    • Conduction disturbance and cardiac arrhythmia,
    • Necessity of permanent pacemaker implantation
  • Device Success [ Time Frame: Index Procedure and Immediate Post-operative ]

    The following parameters will be collected to assess device success:

    1. Successful vascular access, delivery and deployment of the device successful retrieval of the device
    2. Correct position of the device in the proper anatomical location
    3. Intended performance of the prosthetic heart valve:
    4. Only one valve implanted in proper anatomical position
  • Effectiveness [ Time Frame: Prior to discharge, at 3, 6, 12, 24 and 36 months ]

    The following parameters will assess effectiveness:

    • Transvalvular aortic peak pressure gradient
    • Transvalvular aortic mean pressure gradient
    • Effective aortic valve area
    • Paravalvular regurgitation coded according to VARC
    • Transvalvular regurgitation coded according to VARC
    • No clinically significant valve migration/dislocation
    • Absence of mechanical coronary obstruction
    • Functional improvement assessment by NYHA functional classification
  • Quality of Life [ Time Frame: at 12 months ]
    The SF-12v2 Health Survey is an abbreviated version of the SF-36 Health Survey that uses 12 of the SF-36 items to measure functional health and well-being from the patient's point of view. The SF-12v2 is a practical, reliable, and valid measure of physical and mental health.
  • Combined Safety Endpoint [ Time Frame: at 30 days ]

    A combined safety endpoint will be assessed at 30 days consisting of the following variables:

    • All-cause mortality
    • Major stroke
    • Acute kidney injury (Stage 3)
    • Life-threatening or disabling bleeding
    • Major vascular complication
    • Peri-procedural myocardial infarction
    • Repeat surgical or interventional procedure for valve-related dysfunction
  • Combined Efficacy Endpoint [ Time Frame: at 12 months ]

    A combined efficacy endpoint will be assessed consisting of the following variables:

    • All-cause mortality (after > 30 days)
    • Failure of current therapy for AS, requiring hospitalization for symptoms of valve-related or cardiac decompensation
    • Prosthetic heart valve dysfunction
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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 AI
    Intervention: Device: Transcatheter aortic valve replacement
Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Rüter F, de Kroon TL, Lange R, Ensminger S, Wendler O. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. Eur J Cardiothorac Surg. 2016 Nov;50(5):874-881. Epub 2016 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
May 2019
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,   United Kingdom
 
 
NCT01598844
JV03PMS
No
Not Provided
Not Provided
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
July 2017