Longterm Safety and Performance of the JenaValve (JUPITER)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by JenaValve Technology GmbH
Sponsor:
JenaValve Technology GmbH
Information provided by (Responsible Party):
JenaValve Technology GmbH
ClinicalTrials.gov Identifier:
NCT01598844
First received: May 11, 2012
Last updated: December 29, 2014
Last verified: December 2014
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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 |
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 230 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | December 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 aortic insufficiency |
Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access
Other Name: The JenaValve TAVI System
|
Eligibility| Genders Eligible for Study: | Both |
| 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
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, 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
Contacts
| Contact: Petra Hohenadl, Dr. | hohenadl@jenavalve.de |
Locations
| Germany | |
| Herz- und Diabeteszentrum NRW | Recruiting |
| Bad Oeynhausen, Germany | |
| Principal Investigator: S. Ensminger, Prof. Dr. med. | |
| Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden | Recruiting |
| Dresden, Germany | |
| Principal Investigator: U. Kappert, PD Dr. med. | |
| University Hospital | Recruiting |
| Erlangen, Germany | |
| Principal Investigator: R. Feyrer, PD Dr. med. | |
| University Heart Centre | Recruiting |
| Freiburg, Germany | |
| Principal Investigator: F. Beyersdorf, Prof. Dr.Dr. | |
| Asklepios Klinik | Recruiting |
| Hamburg, Germany | |
| Contact: , Dr.med. | |
| Principal Investigator: R Bader, Dr. med. | |
| Universitäres Herzzentrum Hamburg | Recruiting |
| Hamburg, Germany | |
| Principal Investigator: H. Treede, Prof. Dr. | |
| Herzzentrum der Universität | Recruiting |
| Köln, Germany | |
| Principal Investigator: N. Madershahian, PD Dr. med. | |
| Herzzentrum Leipzig - Universitätsklinik | Recruiting |
| Leipzig, Germany | |
| Principal Investigator: D. Holzhey, Dr. med. | |
| Deutsches Herzzentrum München | Recruiting |
| Munich, Germany | |
| Principal Investigator: R. Lange, Prof. Dr. | |
| Herzzentrum des Städtischen Klinikums München | Recruiting |
| Munich, Germany | |
| Principal Investigator: W. Eichinger, PD Dr. med. | |
| Herz- und Kreislaufzentrum Rotenburg (Fulda) | Recruiting |
| Rotenburg (Fulda), Germany | |
| Principal Investigator: A. Rastan, PD Dr. med. | |
| Robert Bosch Krankenhaus Stuttgart | Recruiting |
| Stuttgart, Germany | |
| Principal Investigator: U. Franke, PD Dr. med. | |
| Sub-Investigator: H. Baumbach, Dr. med. | |
| Netherlands | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Principal Investigator: Thom De Kroon, Dr.med. | |
| Switzerland | |
| Universitätsspital Basel | Recruiting |
| Basel, Switzerland | |
| Principal Investigator: F. Rüter, Dr. med. | |
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
No publications provided
| 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: | December 29, 2014 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction |
ClinicalTrials.gov processed this record on February 27, 2015