First in Man Study of the JenaValve TAVI Plus System Transfemoral

Study Overview
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Brief Summary
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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
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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.

Official Title
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First in Man Study of the JenaValve TAVI Plus System Transfemoral

Conditions
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Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: JenaValve Pericardial TAVR System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Aortic Valve Replacement<br>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. | Device: JenaValve Pericardial TAVR System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Index Procedure and Immediate Post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Disease, Aortic Valve Replacement, Transcatheter, Transfemoral, Aortic Stenosis