NCT02818959

First in Man Study of the JenaValve TAVI Plus System Transfemoral

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: JenaValve Technology, Inc. · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2015-05-01
• First posted: 2016-06-30
• Last updated: 2020-05-21

Locations

2 sites across 1 country: Germany