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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.
Full description
This study is the Prospective, Randomized, Controlled, Multi-center Study of Isolated SAVR in Low Risk AS Patients (The AMETHYST trial). Patients will be randomized 1:1 to receive either SAVR or transcatheter heart valve replacement (TAVR) with a commercially available surgical and transcatheter bioprosthetic valves. The aim of this study was to assess the non-inferiority of SAVR compared with TAVR for the combined endpoints of death from any cause, stroke and rehospitalization (hospitalization related to biological valves or procedures or heart failure) at 1 year postoperatively. Patients will be seen for follow-up visits at discharge, 30 days, and annually through 10 years.
Enrollment
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Volunteers
Inclusion criteria
All study participants must meet the following inclusion criteria 1. Severe, calcific aortic stenosis with the following criteria:
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.
Exclusion criteria
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.
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.
Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization
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.
Complex coronary artery disease:
Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization
Leukopenia (WBC < 3000 cell/mL), Thrombocytopenia (Plt < 50,000 cell/mL), history of bleeding diathesis or coagulopathy.
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
Hypertrophic cardiomyopathy with obstruction (HOCM)
Ventricular dysfunction with LVEF < 30%
Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
Stroke or transient ischemic attack (TIA) within 90 days of randomization
Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy
Active bacterial endocarditis within 180 days of randomization
Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
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.
Patient refuses blood products.
BMI > 50 kg/m2
Estimated life expectancy < 24 months.
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication.
Immobility or significant cognitive impairment that would prevent completion of study procedure.
Currently participating in an investigational drug or another device study.
Unsuitable as candidates by the principal investigator or a research associate for other reasons
Primary purpose
Allocation
Interventional model
Masking
800 participants in 2 patient groups
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Central trial contact
Shigeru Miyagawa, M.D.; Koichi Maeda, M.D.
Data sourced from clinicaltrials.gov
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