The JenaValve ALIGN-AR Pivotal Trial

Study Overview
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Brief Summary
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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.

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 symptomatic severe aortic regurgitation.

Official Title
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A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)

Conditions
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Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease

Intervention / Treatment
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* Device: JenaValve Trilogy Heart Valve 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 Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System | Device: JenaValve Trilogy Heart Valve System<br>* TAVR with JenaValve Trilogy Heart Valve System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality at 1 Year | All-cause mortality within the first 12 months post index procedure | 1 year | 
| All Stroke | Number of patients that had a stroke | 30 days | 
| Major Bleeding | Number of patients that had any of these events | 30 days | 
| Acute Kidney Injury | Number of patients that had these events | 30 days | 
| Major Vascular Complications | Number of patients that had these events | 30 days | 
| Surgery/intervention related to the device | Number of patients that had these events | 30 days | 
| Permanent pacemaker implantation | Number of patients that had these events | 30 days | 
| Total aortic regurgitation | Number of patients that had these events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KCCQ | KCCQ Improvement | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valvular Heart Disease, Aortic Incompetence, Aortic Valve Incompetence