Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

A vizsgálat adatai

Ki végzi

Osaka University

Azonosító

NCT06924151

A regiszteradat frissítve

2026. szeptember 4.

Eredeti leírás

To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.A teljes eredeti leírásKevesebb

the Prospective, Randomized, Controlled, Multi-center Study to Establish the Safety and Effectiveness of Isolated Surgical Aortic Valve Replacement in Low Risk Patients Who Have Symptomatic Severe Aortic Stenosis

To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.

Bevonási feltételek: 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; AND 2. NYHA class ≥ II OR Exercisee test that demonstrates a limited exercise capacity, abnormal blood pressure response, or arrhythmia OR Asymptomatic patients with LVEF <50%; 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; 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.

Kizáró feltételek: Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization; Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure; Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen; Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication; Currently participating in an investigational drug or another device study; Candidates will be excluded from the study if any of the following conditions are present:; History of cardiovascular surgery or thoracotomy; Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary; Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR; Complex coronary artery disease:; Heart Team assessment that CABG is recommended at the time of SAVR; Heart Team assessment that optimal revascularization cannot be performed; Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization; Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization; Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation; Stroke or transient ischemic attack (TIA) within 90 days of randomization; Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure); History of cirrhosis or active liver disease; 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; Immobility or significant cognitive impairment that would prevent completion of study procedure; Leukopenia (WBC < 3000 cell/mL), Thrombocytopenia (Plt < 50,000 cell/mL), history of bleeding diathesis or coagulopathy; Ventricular dysfunction with LVEF < 30%; Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy; Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis; Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath; Aortic valve is unicuspid; Severe aortic regurgitation (>3+); Severe mitral regurgitation (>3+) or ≥ moderate stenosis; Severe tricuspid regurgitation (>3+) or ≥ moderate stenosis; Pre-existing mechanical or bioprosthetic valve in any position; Hypertrophic cardiomyopathy with obstruction (HOCM); Active bacterial endocarditis within 180 days of randomization; Patient refuses blood products; BMI > 50 kg/m2; Estimated life expectancy < 24 months; Unsuitable as candidates by the principal investigator or a research associate for other reasons.

ClinicalTrials.gov NCT06924151