JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Study Overview
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Brief Summary
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To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Detailed Description
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This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Official Title
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JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

Conditions
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Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction

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 degenerative native aortic stenosis (AS). Patient at high risk for open surgical valve replacement Patient symptomatic according to NYHA functional class II or higher 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

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>Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system. | Device: JenaValve Pericardial TAVR System<br>* Transcatheter aortic valve replacement (TAVR) will be performed using the 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 | All-cause mortality rate at 30 Day | 30 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Infarction | Peri-procedural and spontaneous myocardial infarction | 30 Day | 
| All Stroke/TIA | Neurological Complications | 30 Day | 
| Major Bleeding | Life threatening or major bleeding | 30 Day | 
| Major Vascular Complication | Major vascular and bleeding complications | 30 Day | 
| Conduction Disturbance and Arrhythmias | Conduction system injury (defect), including AV block, which may require a permanent pacemaker | 30 Day | 
| Acute Kidney Injury (AKI) | Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output <0.5 mL/kg/h for >12 but <24 h AKI Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output <0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h | 30 Day | 
| Coronary Obstruction Requiring Intervention | Coronary obstruction post-implant requiring intervention | 30 Day | 
| Endocarditis | Bacterial endocarditis | 30 Day | 
| Conversion to Surgical Aortic Valve Replacement (SAVR) | Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications | 30 Day | 
| THV Malpositioning | Number of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root | 30 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients