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Longterm Safety and Performance of the JenaValve (JUPITER)
This study is ongoing, but not recruiting participants.
Sponsor:
JenaValve Technology GmbH
Information provided by (Responsible Party):
JenaValve Technology GmbH
ClinicalTrials.gov Identifier:
NCT01598844
First received: May 11, 2012
Last updated: June 2, 2017
Last verified: June 2017
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Purpose
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
| Condition | Intervention |
|---|---|
| Aortic Stenosis Aortic Insufficiency | Device: Transcatheter aortic valve replacement |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | "The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere AoRtic Stenosis |
Resource links provided by NLM:
Further study details as provided by JenaValve Technology GmbH:
Primary Outcome Measures:
- 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:
- 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
- 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
| Enrollment: | 210 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2019 |
| Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
Eligibility| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598844
Please refer to this study by its ClinicalTrials.gov identifier: 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 (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 |
More Information
| Responsible Party: | JenaValve Technology GmbH |
| ClinicalTrials.gov Identifier: | NCT01598844 History of Changes |
| Other Study ID Numbers: |
JV03PMS |
| Study First Received: | May 11, 2012 |
| Last Updated: | June 2, 2017 |
Additional relevant MeSH terms:
|
Constriction, Pathologic Aortic Valve Stenosis Aortic Valve Insufficiency Pathological Conditions, Anatomical |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |
ClinicalTrials.gov processed this record on June 28, 2017