JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation (JUPITER)
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ClinicalTrials.gov Identifier: NCT01598844 |
Recruitment Status :
Completed
First Posted : May 15, 2012
Last Update Posted : November 24, 2020
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Condition or disease | Intervention/treatment |
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Aortic Stenosis Aortic Insufficiency Aortic Regurgitation | Device: Transcatheter aortic valve replacement |
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 |
Actual Study Start Date : | May 30, 2012 |
Actual Primary Completion Date : | August 27, 2015 |
Actual Study Completion Date : | July 31, 2018 |

Group/Cohort | Intervention/treatment |
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High risk patients with aortic stenosis
Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis.
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Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Name: The JenaValve TAVI System |
High risk patients with AI
Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation.
|
Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Name: The JenaValve TAVI System |
- 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.
- 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:
- 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
- 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
- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
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 |
Principal Investigator: | Olaf Wendler, Prof | King's College Hospital, London | |
Principal Investigator: | Hendrik Treede, Prof | University Heart Center Hamburg |
Other Publications:
Responsible Party: | JenaValve Technology, Inc. |
ClinicalTrials.gov Identifier: | NCT01598844 |
Other Study ID Numbers: |
JV03PMS |
First Posted: | May 15, 2012 Key Record Dates |
Last Update Posted: | November 24, 2020 |
Last Verified: | November 2020 |
Aortic Valve Stenosis Aortic Valve Insufficiency Constriction, Pathologic Pathological Conditions, Anatomical Aortic Valve Disease |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |