Moderate AS
Conditions
Interventions
Transcatheter aortic valve replacement using EWJ-003
Sponsors
NAKAZAWA GAKU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees toits provisions, and has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe placement of the introducer sheath or safepassage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta >4.5 cm or severe raphe/leafletcalcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF < 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significantparavalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus,or vegetation 11. Coronary or aortic valve anatomy that increases the risk ofcoronary artery obstruction post-TAVR etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoint [ Time Frame: 2 years ] Non-hierarchical composite of death, and heart failure hospitalization or event Primary Safety Endpoint [ Time Frame: 30 days ] Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention | — |
Secondary
| Measure | Time frame |
|---|---|
| -Death, stroke, or unplanned cardiovascular hospitalization [ Time Frame: 2 years ] The number of patients that had this event -Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 2 years ] The number of patients that met all of these criteria -Unplanned cardiovascular hospitalization [ Time Frame: 2 years ] The number of patients that had this event -Left ventricle (LV) mass index [ Time Frame: 2 years ] Echocardiographic measurement of the size of the left ventricle -Stroke volume index [ Time Frame: 2 years ] Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction. -Diastolic dysfunction >= Grade 2 [ Time Frame: 2 years ] Echocardiographic measurement of the stiffness of the left ventricle. -N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) [ Time Frame: 2 years ] NT-ProBNP is a hormone that measures heart failure. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable. -KCCQ overall score [ Time Frame: 2 years ] Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. -Reduction in LVEF >= 5% from baseline AND LVEF < 60% [ Time Frame: 2 years ] The number of patients that meet these criteria -New onset atrial fibrillation [ Time Frame: 2 years ] The number of patients that develop this condition | — |
Countries
Australia, Canada, Japan, Netherlands, Switzerland, US
Contacts
Public ContactKikumi Kitayama
Edwards Lifesciences Japan LLC
Outcome results
None listed