Aortic StenosisJUPITERNCT01598844
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
An observational study of Aortic Stenosis and Aortic Insufficiency, run by JenaValve Technology, Inc. at 15 sites in 4 countries.
Trial summary
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 210 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 30 May 2012to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe aortic stenosis or with severe aortic insufficiency and an increased risk for an open aortic valve replacement surgery
Who may be able to join
- Patients suitable for TAVI with the JenaValve according to instructions for use
Who cannot join
- Patients unsuitable for TAVI with the JenaValve according to instructions for use
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany12 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Herzzentrum der Universität
Cologne
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden
University Hospital
Erlangen
University Heart Centre
Freiburg im Breisgau
Asklepios Klinik
Hamburg
Universitäres Herzzentrum Hamburg
Hamburg
Herzzentrum Leipzig - Universitätsklinik
Leipzig
Deutsches Herzzentrum München
Munich
Herzzentrum des Städtischen Klinikums München
Munich
Herz- und Kreislaufzentrum Rotenburg (Fulda)
Rotenburg an der Fulda
Robert Bosch Krankenhaus Stuttgart
Stuttgart
About this study
Official title: The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
Read the 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.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Being tested
- Transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementDevice
Also called The JenaValve TAVI System
Transcatheter aortic valve replacement via a transapical access
| Study group | Role | What they receive |
|---|---|---|
| High risk patients with aortic stenosis | Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis. Receives: Device: Transcatheter aortic valve replacement | |
| High risk patients with AI | Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation. Receives: Device: Transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
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.
Measured: 30 day
Secondary outcomes (6)
Safety Endpoints
- 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
Measured: peri- and post-operatively and at 3, 6, 12, 24 and 36 months
Device Success
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
Measured: Index Procedure and Immediate Post-operative
Device Effectiveness
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
Measured: Prior to discharge, at 3, 6, 12, 24 and 36 months
SF-12 Survey of Quality of Life
The SF-12 health survey to measure mental and physical health of the patient.
Measured: at 12 months
Combined Safety Endpoint
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
Measured: at 30 days
Combined Efficacy Endpoint
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
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study start30 May 2012
- Primary completion27 Aug 2015
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- JenaValve Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King's College London, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Olaf Wendler, Prof, Principal investigator, King's College Hospital NHS TrustHendrik Treede, Prof, Principal investigator, University Heart Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598844
- Sponsor's protocol ID
- JV03PMS
- Acronym
- JUPITER
- Status last verified
- Nov 2020
- First submitted
- 11 May 2012
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Mieres J, Menendez M, Fernandez-Pereira C, Rubio M, Rodriguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol. 2015;2015:458151. doi: 10.1155/2015/458151. Epub 2015 Aug 4.
PubMed 26346128Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schafer U, Diemert P, Treede H. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13.
PubMed 25129672Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Ruter 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. doi: 10.1093/ejcts/ezw170. Epub 2016 May 30.
PubMed 27242354Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 2018 Jun;91(7):1345-1351. doi: 10.1002/ccd.27370. Epub 2017 Nov 24.
PubMed 29171730
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency
- ClinicalTrials.gov ID
- NCT01598844
- Acronym / sponsor ID
- JUPITER / JV03PMS
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- JenaValve Technology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- King's College London, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 30 May 2012 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk patients with aortic stenosis | – | Device: Transcatheter aortic valve replacementTransapical aortic valve implantation using a transcatheter heart valve for aortic stenosis. |
| High risk patients with AI | – | Device: Transcatheter aortic valve replacementTransapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe aortic stenosis or with severe aortic insufficiency and an increased risk for an open aortic valve replacement surgery
Key inclusion criteria (1 listed)
- Patients suitable for TAVI with the JenaValve according to instructions for use
Key exclusion criteria (1 listed)
- Patients unsuitable for TAVI with the JenaValve according to instructions for use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacementAlso: The JenaValve TAVI SystemTranscatheter aortic valve replacement via a transapical access | Device | High risk patients with AI, High risk patients with aortic stenosis |
Primary outcome
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.
6 secondary outcomes
Safety Endpoints
Time frame: peri- and post-operatively and at 3, 6, 12, 24 and 36 months
Device Success
Time frame: Index Procedure and Immediate Post-operative
Device Effectiveness
Time frame: Prior to discharge, at 3, 6, 12, 24 and 36 months
SF-12 Survey of Quality of Life
Time frame: at 12 months
Combined Safety Endpoint
Time frame: at 30 days
Combined Efficacy Endpoint
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 26346128Mieres J, Menendez M, Fernandez-Pereira C, Rubio M, Rodriguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol. 2015;2015:458151. doi: 10.1155/2015/458151. Epub 2015 Aug 4.
- Background: PubMed 25129672Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schafer U, Diemert P, Treede H. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13.
- Results publication: PubMed 27242354Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Ruter 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. doi: 10.1093/ejcts/ezw170. Epub 2016 May 30.
- Results publication: PubMed 29171730Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 2018 Jun;91(7):1345-1351. doi: 10.1002/ccd.27370. Epub 2017 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Wendler, Prof principal investigator
King's College Hospital NHS Trust
Hendrik Treede, Prof principal investigator
University Heart Center Hamburg
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Aortic Insufficiency, run by JenaValve Technology, Inc. at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Netherlands, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598844, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.