Brief Title
First in Man Study of the JenaValve TAVI Plus System Transfemoral
Official Title
First in Man Study of the JenaValve TAVI Plus System Transfemoral
Brief Summary
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
Detailed Description
The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.
Study Type
Interventional
Primary Outcome
All-Cause Mortality
Secondary Outcome
Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints
Condition
Aortic Valve Stenosis
Intervention
JenaValve Pericardial TAVR System
Study Arms / Comparison Groups
Transcatheter Aortic Valve Replacement
Description: In this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended for use in subjects with severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using a delivery system.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
7
Start Date
December 2013
Completion Date
May 2015
Primary Completion Date
March 2014
Eligibility Criteria
Inclusion Criteria: - Diagnosed with severe native aortic valve stenosis - NYHA functional class II or higher - Increased risk for surgical aortic valve replacement - Comply with post-operative follow-up visits and requirements Exclusion Criteria: - Combined aortic valve disease with severe aortic insufficiency - Presence of moderate mitral insufficiency or previous mitral prosthesis - Severe pulmonary hypertension - Congenital uni- or bicuspid aortic valve - Endocarditis or active infection - Life expectancy < 12 months - Need for emergency surgery for any reason
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stephan Baldus, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02818959
Organization ID
JV04FIM
Responsible Party
Sponsor
Study Sponsor
JenaValve Technology, Inc.
Study Sponsor
Stephan Baldus, MD, Principal Investigator, University of Koln Medical Center
Verification Date
May 2020