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

Purpose

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.

Conditions

  • Aortic Regurgitation
  • Aortic Valve Insufficiency
  • Aortic Insufficiency
  • Aortic Valve Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcatheter Aortic Valve Replacement (TAVR)
TAVR with JenaValve Pericardial Valve and Delivery System Intervention Device: JenaValve Pericardial TAVR System
  • Device: JenaValve Pericardial TAVR System
    TAVR with JenaValve Pericardial Valve and Delivery System

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Erin Collins
202-877-6622
Erin.C.Collins@medstar.net

More Details

Status
Recruiting
Sponsor
JenaValve Technology, Inc.

Study Contact

Vinny Podichetty, Vice President: Clinical & Med Affairs
949-396-7510
podichetty@jenavalve.com

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.