Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease

Study Overview
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Brief Summary
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A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.

Official Title
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Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Ventor Embracer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient understands the implications of participating in the study and provides informed consent Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone Age >75 years Severe, aortic stenosis (echocardiographically derived mean gradient > 40 mm Hg, and/or jet velocity > 4m/s, or an initial aortic valve area of < 0.8 cm2) Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater EuroSCORE scale of >9 points indicating a predicted risk for mortality of >11% according to the logistic EuroSCORE Echocardiographically determined anteroposterior aortic annulus diameter of >19 and <23 mm Echocardiographically determined sinotubular junction diameter of ≥23 mm Exclusion Criteria: Congenital unicuspid or bicuspid aortic valve Fused commissures Severe eccentricity of calcification Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Severe left ventricular dysfunction (LVEF < 25%) More than mild right ventricular dysfunction Hypertrophic obstructive cardiomyopathy Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months Known hypersensitivity or contraindication to any study medication Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication Known allergy or sensitivity to Nitinol Sepsis, or acute endocarditis Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy. Renal insufficiency and/or end stage renal disease requiring chronic dialysis Liver disease as indicated by jaundice, ascites, ALT/AST > 3 x ULN, elevation of total bilirubin > 1.5 mg/dl, albumin < 3.0 g/l, or INR > 1.5 (if not on anticoagulation). Significant lung disease (e.g. FEV1 < 1.2L or FEV1 < 50%). Active peptic ulcer or GI bleeding within 3 months from the planned index procedure Untreated clinically significant coronary artery disease requiring revascularisation Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump) Need for emergency surgery, cardiac or noncardiac History of myocardial infarction in the last 6 weeks. History of TIA or stroke in the last 6 months. Any therapeutic invasive cardiac procedure, except aortic balloon valvuloplasty, performed within 30 days from the planned index procedure, or 6 months, in case of implantation of drug-eluting stents. Uncontrolled atrial fibrillation Pre-existing aortic valve replacement Severe (greater than 3+) mitral regurgitation Severe (greater than 3+) aortic regurgitation Patient is currently enrolled in another investigational device or drug trial

Ages Eligible for Study
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Minimum Age: 75 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: 1<br>Embracer implantation | Device: Ventor Embracer<br>* Implantation of Ventor Embracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure |  | day one | 
| A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success and the absence of periprocedural MACCEs at post-operative day 1 |  | day one | 
| Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days |  | 30 days | 
| Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months |  | 6 months | 
| Freedom from death at 1 year |  | 1 year | 
| Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year |  | 1 year | 
| Peak & mean pressure gradient, derived calculated measures of prosthetic valve function, aortic regurgitation - assessed by echocardiography immediately after deployment, at POD 1, 30 days, 6 months and 5 years annually |  | 5 years |