Clinical trial NCT02818959: First in Man Study of the JenaValve TAVI Plus System Transfemoral
Official title: First in Man Study of the JenaValve TAVI Plus System Transfemoral
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Keywords: Aortic Valve Disease
Aortic Valve Replacement
Transcatheter
Transfemoral
Aortic Stenosis
Lead sponsor: JenaValve Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-30
Enrollment: 7
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: All-Cause Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints
timeFrame: Index Procedure and Immediate Post-operative
Other outcomes:
measure: Device Success
timeFrame: Index Procedure and Immediate Post-operative
measure: Clinical Outcomes through 2-year follow-up - Hemodynamic Performance
timeFrame: Prior to discharge, at 3, 6, 12 and 24 months
measure: Clinical Outcomes through 2-year follow-up - NYHA Functional Classification
timeFrame: Prior to discharge, at 3, 6, 12 and 24 months
Locations:
city: Hamburg
country: Germany
facility: University of Hamburg Medical Center
city: Koln
country: Germany
facility: University of Koln Medical Center
Study officials:
affiliation: University of Koln Medical Center
name: Stephan Baldus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hamburg Medical Center
name: Hendrik Treede, MD
role: PRINCIPAL_INVESTIGATOR
References: