THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- JenaValve Technology, Inc.
- Enrollment
- 100
- Locations
- 37
- Primary Endpoint
- All-Cause Mortality at 30 days
Study Overview
Brief Summary
To collect information about treatment for 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.
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 severe aortic regurgitation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
All-Cause Mortality at 30 days
Time Frame: 30 days
All-Cause mortality within the first 30 days post index procedure
Secondary Outcomes
- Stroke-Free Survival(At 30 days and 1 year)
- Peri-Procedural Myocardial Infarction(At ≤72hr after the index procedure)
- Mortality(At 30 days)
- Bleeding & Vascular Complications(30 days)