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

Ventor Technologies

Status: Unknown

Conditions: Aortic Valve Disease

Treatments: Device: Ventor Embracer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677638

CLIN004

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient understands the implications of participating in the study and provides informed consent
2. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
3. Age >75 years
4. 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)
5. Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater
6. EuroSCORE scale of >9 points indicating a predicted risk for mortality of >11% according to the logistic EuroSCORE
7. Echocardiographically determined anteroposterior aortic annulus diameter of >19 and <23 mm
8. Echocardiographically determined sinotubular junction diameter of ≥23 mm

Exclusion criteria

1. Congenital unicuspid or bicuspid aortic valve
2. Fused commissures
3. Severe eccentricity of calcification
4. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
5. Severe left ventricular dysfunction (LVEF < 25%)
6. More than mild right ventricular dysfunction
7. Hypertrophic obstructive cardiomyopathy
8. Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months
9. Known hypersensitivity or contraindication to any study medication
10. Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication
11. Known allergy or sensitivity to Nitinol
12. Sepsis, or acute endocarditis
13. Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
14. Renal insufficiency and/or end stage renal disease requiring chronic dialysis
15. 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).
16. Significant lung disease (e.g. FEV1 < 1.2L or FEV1 < 50%).
17. Active peptic ulcer or GI bleeding within 3 months from the planned index procedure
18. Untreated clinically significant coronary artery disease requiring revascularisation
19. Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance
20. Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump)
21. Need for emergency surgery, cardiac or noncardiac
22. History of myocardial infarction in the last 6 weeks.
23. History of TIA or stroke in the last 6 months.
24. 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.
25. Uncontrolled atrial fibrillation
26. Pre-existing aortic valve replacement
27. Severe (greater than 3+) mitral regurgitation
28. Severe (greater than 3+) aortic regurgitation
29. Patient is currently enrolled in another investigational device or drug trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

Embracer implantation

Treatment:

Device: Ventor Embracer