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Longterm Safety and Performance of the JenaValve (JUPITER)

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.
ClinicalTrials.gov Identifier: NCT01598844
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology GmbH

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

Condition or disease Intervention/treatment
Aortic Stenosis Aortic Insufficiency Device: Transcatheter aortic valve replacement

Detailed Description:

The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement.

The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.


Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency"
Study Start Date : May 2012
Primary Completion Date : September 2015
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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 AI Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Name: The JenaValve TAVI System



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 An Der Fulda, Germany
Robert Bosch Krankenhaus Stuttgart
Stuttgart, Germany
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Switzerland
Universitätsspital Basel
Basel, Switzerland
United Kingdom
King's College Hospital
London, United Kingdom
Sponsors and Collaborators
JenaValve Technology GmbH
Investigators
Principal Investigator: Olaf Wendler, Prof King's College Hospital, London
Principal Investigator: Hendrik Treede, Prof UKE Hamburg