To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  • Patient with severe aortic regurgitation (AR). - Patient at high risk for open surgical valve replacement - Patient symptomatic according to NYHA functional class II or higher - The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

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 - Severe mitral regurgitation

Study Design

Study Type
Intervention Model
Single Group Assignment
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Transcatheter Aortic Valve Replacement (TAVR)
TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
  • Device: JenaValve Trilogy Heart Valve System
    TAVR with JenaValve Trilogy Heart Valve System

More Details

Active, not recruiting
JenaValve Technology, Inc.

Study Contact

Detailed Description

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.