First in Man Study of the JenaValve TAVI Plus System Transfemoral

Not Applicable

Terminated

• Conditions: Heart Diseases; Heart Valve Diseases; Aortic Valve Stenosis; Cardiovascular Diseases
• Interventions: Device: JenaValve Pericardial TAVR System

• Registration Number: NCT02818959
• Lead Sponsor: JenaValve Technology, Inc.

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 Timeline

• Study Start: 2013-12
• Primary Completion: 2014-03
• Study Completion: 2015-05
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve Replacement	JenaValve Pericardial TAVR System	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.

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints	Index Procedure and Immediate Post-operative	* Myocardial Infarction; * Stroke; * Major Bleeding; * Acute Kidney Injury; * Vascular Complications; * Conduction Disturbances and Arrhythmias; * TAVR-related Complications

Trial Locations

Locations (2)

University of Hamburg Medical Center; 🇩🇪 Hamburg, Germany

University of Koln Medical Center; 🇩🇪 Koln, Germany