Aortic Stenosis
Conditions
Interventions
Investigational Device Group
For study participants undergoing SAVR, commercially available surgical bioprosthetic valves and related components will be used according to the standard of care at the p
Sponsors
Maeda Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) All study participants must meet the following inclusion criteria 1.Severe, calcific aortic stenosis with the following criteria: Jet velocity >=4.0 m/s or mean gradient >= 40 mmHg OR AVA = 2 OR Exercise test that demonstrates a limited exercise capacity, abnormal blood pressure response, or arrhythmia OR Asymptomatic patients with LVEF <50% (2) The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation of overall clinical status and comorbidities that may not be adequately captured by risk calculators such as STS-PROM, in addition to the risk score itself. (3) The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified review board.
Exclusion criteria
Exclusion criteria: (1) History of cardiovascular surgery or thoracotomy (2) Pre-existing other valvular disease, coronary artery disease or aortic disease requiring intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary. (3) Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR. (4) Native aortic annulus size unsuitable for sizes of the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis. (5) Iliofemoral vessel characteristics that would preclude safe insertion of the introducer sheath. (6) Evidence of an acute myocardial infarction or PCI 3+) (9) Severe mitral regurgitation (>3+) or >= moderate stenosis (10) Severe tricuspid regurgitation (>3+) or >= moderate stenosis (11) Pre-existing mechanical or bioprosthetic valve in any position. (12) Complex coronary artery disease: (a) Heart Team assessment that CABG is recommended at the time of SAVR (b) Heart Team assessment that optimal revascularization cannot be performed (13) Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization (14) Leukopenia (WBC = 2/3 systemic pressure) (25) History of cirrhosis or active liver disease (26) Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation, etc.) that would preclude cannulation and aortotomy for SAVR or safe passage of the delivery system for TAVR. (27) Patient refuses blood products. (28) BMI > 50 kg/m2 (29) Estimated life expectancy < 24 months. (30) Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication. (31) Immobility or significant cognitive impairment that would prevent completion of study procedure. (32) Currently participating in an investigational drug or another device study. (33) Unsuitable as candidates by the principal investigator or a research associate for other reasons This revision replaces full-width characters and symbols with their half-width counterparts where applicable, ensuring compliance with input restrictions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure) at 1 year post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) the rate of all-cause mortality or disabling stroke at one year (2) the rate of all-cause mortality at one year (3) the rate of all stroke at one year (4) the rate of disabling stroke at one year (5) the rate of rehospitalization (valve-related or procedure-related and including heart failure) at one year (6) the rate of new bundle branch block or new pacemaker implantation at one year (7) the rate of new onset of atrial fibrillation at 30 days (8) the rate of life-threatening bleeding at one year (9) the rate of occurrence of perivalvular regurgitation >-mild by echocardiography at one year (10) Quality of life as assessed by KCCQ at one year (11) Quality of life as assessed by EQ-5D-5L at one year (12) the rate of prosthetic valve endocarditis at one year (13) the rate of prosthetic valve thrombosis at one year (14) the rate of valve-related dysfunction requiring repeat procedure at one year | — |
Contacts
Public ContactKoichi Maeda
The University of Osaka Hospital
Outcome results
None listed