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

Ventor Technologies3 sites in 1 country30 target enrollmentJune 2008

ConditionsAortic Valve Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Disease
Sponsor: Ventor Technologies
Enrollment: 30
Locations: 3
Primary Endpoint: Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

December 2014

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ventor Technologies

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure

Time Frame: day one

A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure

Time Frame: 30 days

Secondary Outcomes

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)