Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time to death
研究概览
简要总结
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
详细描述
Stenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood flow from the heart into the Aorta, and is associated with symptoms like fatigue, breathlessness, dizziness, fainting, and chest pain. For many of the patients suffering from severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged aortic valve has been proven to be a safe and effective treatment option.
Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation from the usually observed disease pattern: These patients do not show the typical high pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular gradient; "paradoxical" low flow/low gradient aortic stenosis). For these patients it is not yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair - TAVR) should be a treatment option as well.
REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment alone for patients suffering from paradoxical aortic stenosis. Two thirds of the participating patients will be treated by TAVR, one third will receive medical Treatment alone.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic native aortic valve stenosis and age ≥18 years
- •Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2
- •Left ventricular ejection fraction ≥ 50%
- •MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
- •Heart team agrees on eligibility for TAVR
- •Written informed consent
- •Negative pregnancy test in women with childbearing potential
排除标准
- •Hemodynamic instability
- •Cardiogenic shock
- •Pre-existing mechanical or bio-prosthetic valve in any position
- •Concomitant severe valvular heart disease
- •Pre-existing or active endocarditis
- •Need for heart surgery due to other conditions
- •Aortic valve is congenital unicuspid or congenital bicuspid
- •Hypertrophic cardiomyopathy with or without obstruction
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Acute myocardial infarction within 1 month before intended AS-treatment
- •Renal replacement therapy
- •Estimated life expectancy < 24 months (730 days) due to carcinomas end stage liver disease or renal disease
- •Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- •Patient refuses aortic valve repair
研究组 & 干预措施
TAVR Group
Patients will be treated by transcatheter aortic valve repair (TAVR).
干预措施: TAVR (Device)
Medical Treatment Group
Patients will receive optimal medical treatment alone.
结局指标
主要结局
Time to death
时间窗: 24 months after last-patient-in
All-cause mortality
次要结局
- Device reliability(5 years after randomization)
- Incidence of neurological events - incidence of strokes(5 years after randomization)
- Cardiac functionality - aortic valve hemodynamics(5 years after randomization)
- Patients' quality of life(5 years after randomization)
- Cardiovascular mortality(5 years after index treatment)
- Re-hospitalization due to heart failure(5 years after index treatment)
- Incidence of neurological Events - incidence of transient ischaemic attacks(5 years after randomization)
- Cardiac functionality - left ventricular function(5 years after randomization)