Research Study: ALIGN AR
Condition:
Valvular Disease (Heart Valve Disease), Aortic Regurgitation
Study Sponsor:
JenaValve Technology, Inc.
Study Investigator:
Dr. Paul Sorajja
Study Contact:
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
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.
Eligibility Criteria:
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
