Skip to main content
OpenTrials
Completed

NCT Number: NCT01598844

JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Stenosis Aortic Insufficiency Aortic Regurgitation Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter Aortic Valve Replacement

Device

Transcatheter aortic valve replacement via a transapical access

Other names: The JenaValve TAVI System

Primary outcomes

  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 outcomes

  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:

    • Successful vascular access, delivery and deployment of the device successful retrieval of the device
    • Correct position of the device in the proper anatomical location
    • Intended performance of the prosthetic heart valve:
    • Only one valve implanted in proper anatomical position

  3. Device 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. SF-12 Survey of Quality of Life

    Time frame: at 12 months

    The SF-12 health survey to measure mental and physical health of the patient.

  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

Sponsors and collaborators

Lead sponsor

JenaValve Technology, Inc.

Industry

Collaborators

  • King's College London
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency

Acronym: JUPITER

Important dates

Study start
2012
Primary completion
2015
Study completion
2018
First posted
May 15, 2012
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.