Status:
UNKNOWN
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
Lead Sponsor:
Ventor Technologies
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
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 di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00677638
Start Date
June 1 2008
End Date
December 1 2014
Last Update
December 3 2009
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Prof. Thorsten Wahlers
Cologne, Germany, 50924
2
Prof. Jochen Schaefers
Homburg, Germany, 66421
3
Friedrich Mohr, MD
Leipzig, Germany, 04289