First in Man Study of the JenaValve TAVI Plus System Transfemoral

NCT ID: NCT02818959

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-05-31

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.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcatheter Aortic Valve Replacement

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.

Group Type: EXPERIMENTAL

JenaValve Pericardial TAVR System

Intervention Type: DEVICE

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.

Interventions

JenaValve Pericardial TAVR System

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JenaValve Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Baldus, MD

Role: PRINCIPAL_INVESTIGATOR

University of Koln Medical Center

Hendrik Treede, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hamburg Medical Center

Locations

University of Koln Medical Center

Cologne, , Germany

University of Hamburg Medical Center

Hamburg, , Germany

Countries

Germany

Other Identifiers

JV04FIM

Identifier Type: -

Identifier Source: org_study_id