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First in Man Study of the JenaValve TAVI Plus System Transfemoral

NCT02818959 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-05-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • JenaValve Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephan Baldus, MD · University of Koln Medical Center

  • Hendrik Treede, MD · University of Hamburg Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-03-31
Completion
2015-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818959 on ClinicalTrials.gov