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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Aortic Regurgitation

Intervention / Treatment
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* Device: JenaValve Pericardial TAVR System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Aortic Valve Replacement (TAVR)<br>TAVR with JenaValve Pericardial Valve and Delivery System | Device: JenaValve Pericardial TAVR System<br>* TAVR with JenaValve Pericardial Valve and Delivery System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality at 30 days | All-Cause mortality within the first 30 days post index procedure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Absence of procedural mortality | At 30 days | 
| Peri-Procedural Myocardial Infarction | Peri-procedural and spontaneous myocardial infarction | At ≤72hr after the index procedure | 
| Stroke-Free Survival | Disabling or non-disabling stroke | At 30 days and 1 year | 
| Bleeding & Vascular Complications | Major and minor bleeding | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Disease, Aortic Regurgitation, Aortic Insufficiency