First in Man Study of the JenaValve TAVI Plus System Transfemoral

JenaValve Technology, Inc.7 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases

Interventions

JenaValve Pericardial TAVR SystemDEVICE

The JenaValve Pericardial TAVI system is intended for use in subjects with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement.

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Koln Medical Center

Cologne, Germany

University of Hamburg Medical Center

Hamburg, Germany

Outcomes

Primary Outcomes

All-Cause Mortality

30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve Plus Prosthesis irrespective of the underlying cause of death.

Time frame: 30 days

Secondary Outcomes

Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints

* Myocardial Infarction * Stroke * Major Bleeding * Acute Kidney Injury * Vascular Complications * Conduction Disturbances and Arrhythmias * TAVR-related Complications

Time frame: Index Procedure and Immediate Post-operative

Data from ClinicalTrials.gov

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