THE ALIGN-AR PIVOTAL TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

  • STATUS
    Recruiting
  • End date
    Dec 5, 2025
  • participants needed
    50
  • sponsor
    JenaValve Technology, Inc.
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Updated on 16 February 2024
See if I qualify
regurgitation
aortic valve replacement
fatigue
shortness of breath

Summary

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.

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.

Details
Condition Aortic Regurgitation, VALVULAR HEART DISEASE, Aortic Valve Disease
Age 18years - 100years
Treatment JenaValve Pericardial TAVR System
Clinical Study IdentifierNCT04415047
SponsorJenaValve Technology, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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