NCT06924151招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 77
- 主要终点
- Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All study participants must meet the following inclusion criteria
- •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
- •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.
排除标准
- •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:
- •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
- •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
研究组 & 干预措施
Surgical aortic valve replacement
Experimental
Surgical aortic valve replacement (SAVR) with free choice of surgical bioprosthesis and free choice of surgical access according to the surgeon's preference
干预措施: surgical aortic valve replacement (Procedure)
Transcatheter aortic valve replacement
Active Comparator
Transcatheter aortic valve replacement (TAVR) using the device available in Japan in facilities approved to perform TAVR.
干预措施: Transcatheter aortic valve replacement (Procedure)
结局指标
主要结局
Composite endpoint of all-cause mortality, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure)
时间窗: at 1 year post procedure
次要结局
- the rate of all-cause mortality or disabling stroke(at one year)
- the rate of all-cause mortality(at one year)
- the rate of all stroke(at one year)
- the rate of disabling stroke(at one year)
- the rate of rehospitalization (valve-related or procedure-related and including heart failure)(at one year)
- the rate of new bundle branch block or new pacemaker implantation(at one year)
- the rate of new onset of atrial fibrillation(at 30 days)
- the rate of life-threatening bleeding(at one year)
- the rate of occurrence of perivalvular regurgitation ≥ mild by echocardiography(at one year)
- Quality of life as assessed by KCCQ(at one year)
- Quality of life as assessed by EQ-5D-5L(at one year)
- the rate of prosthetic valve endocarditis(at one year)
- the rate of prosthetic valve thrombosis(at one year)
- the rate of valve-related dysfunction requiring repeat procedure(at one year)
研究者
研究点 (77)
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