Overview

This trial is active, not recruiting.

Conditions aortic stenosis, aortic insufficiency
Treatment transcatheter aortic valve replacement
Sponsor JenaValve Technology GmbH
Start date May 2012
End date September 2015
Trial size 210 participants
Trial identifier NCT01598844, JV03PMS

Summary

The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
transcatheter aortic valve replacement The JenaValve TAVI System
Transcatheter aortic valve replacement via a transapical access
transcatheter aortic valve replacement The JenaValve TAVI System
Transcatheter aortic valve replacement via a transapical access

Primary Outcomes

Measure
all-cause mortality
time frame: 30 day

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients suitable for TAVI with the JenaValve according to instructions for use Exclusion Criteria: - Patients unsuitable for TAVI with the JenaValve according to instructions for use

Additional Information

Official title "The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere AoRtic Stenosis
Principal investigator Olaf Wendler, Prof
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by JenaValve Technology GmbH.