UnknownNot Applicable

JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

United States, Germany68 participantsStarted 2016-10-21

Plain-language summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with severe degenerative native aortic stenosis (AS). * Patient at high risk for open surgical valve replacement * Patient symptomatic according to NYHA functional class II or higher Exclusion Criteria: * Congenital uni- or bicuspid aortic valve morphology * Previous prosthetic aortic valve (bioprosthesis or mechanical) implant * Endocarditis or other active infection * Need for urgent or emergent TAVR procedure for any reason * Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

What they're measuring

All-Cause Mortality

Timeframe: 30 Day

Trial details

NCT IDNCT02732691

SponsorJenaValve Technology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-28

Results submitted2022-09-07

View on ClinicalTrials.gov More Aortic Valve Stenosis trials