JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Status unconfirmed · Not applicable

Conditions studied: Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction

In brief

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.

Key facts

Study ID

NCT02732691

Run by

JenaValve Technology, Inc.

People needed

68

Starts

2016-10-21

Expected to finish

2024-04-01

Last updated by the study team

2022-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Columbia University Medical Center — New York, New York, United States
• Deutsches Herzzentrum Berlin — Berlin, Germany
• Herzzentrum der Universität zu Köln — Cologne, Germany
• Universitäts-Herzzentrum Freiburg/Bad Krozingen — Freiburg im Breisgau, Germany
• Universitätsklinikum Halle — Halle, Germany
• Universitäres Herzzentrum Hamburg — Hamburg, Germany
• Robert-Bosch-Krankenhaus — Stuttgart, Germany
• Leiden University Medical Center — Leiden, Netherlands
• St. Antonius Hospital — Nieuwegein, Netherlands
• Erasmus University Medical Center — Rotterdam, Netherlands
• Auckland City Hospital — Auckland, New Zealand
• Waikato Hospital — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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