The prospective, randomized, controlled, multi-center study of isolated surgical aortic valve replacement in low risk AS patients

JRCT ID: jRCT1052240265

Registered date:07/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Aortic Stenosis
• Date of first enrollment: 07/02/2025
• Target sample size: 800
• Study type: Interventional

Intervention(s)

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 participating medical institutions.

Control Device Group
For study participants undergoing TAVR, commercially available transcatheter bioprosthetic valves and related components will be used according to the standard of care at the participating medical institutions.

Outcome(s)

Primary Outcome

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 Outcome

(1) >= mild PVL on echocardiography at 1 year post procedure
(2) Risk of coronary obstruction during Valve-in-Valve procedure
(3) New-onset bundle branch block or new pacemaker implantation at 1 year post procedure
(4) Leaflet thrombosis at 30 days post procedure
(5) Left ventricular mass regression at 1 year post procedure
(6) All cause mortality at 1 year post procedure
(7) All stroke at 1 year post procedure
(8) Rehospitalization at 1 year post procedure (valve-related or procedure-related and including heart failure)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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 <=1.0 cm2 or AVA index <= 0.6 cm2/m2
Note: Qualifying TTE must be within 90 days prior to randomization
2.NYHA class >= 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.

Exclude 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 <= 30 days before randomization
(7) Aortic valve is unicuspid
(8) Severe aortic regurgitation (>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 < 3000 cell/mL), Thrombocytopenia (Plt < 50,000 cell/mL), history of bleeding diathesis or coagulopathy.
(15) Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
(16) Hypertrophic cardiomyopathy with obstruction (HOCM)
(17) Ventricular dysfunction with LVEF < 30%
(18) Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
(19) Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
(20) Stroke or transient ischemic attack (TIA) within 90 days of randomization
(21) Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy
(22) Active bacterial endocarditis within 180 days of randomization
(23) Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
(24) Severe pulmonary hypertension (e.g., PA systolic pressure >= 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.

Related Information

• Primary Sponsor: Maeda Koichi