Better Patient Selection to Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- MACE
研究概览
简要总结
This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.
详细描述
In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.
排除标准
- •Aortic valve endocarditis
- •aortic annulus >31mm
- •preoperative pacemaker
- •severe aortic insufficiency (>grad 3)
- •rapid atrial fibrillation
- •unprotected left main coronary stenosis not suitable for percutaneous intervention.
- •unstable angina
- •life expectancy less than 12 months
- •mental disorder including dementia and condition which interferes with protocol compliance.
- •renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
- •Patients with metal not suitable for MRI.
结局指标
主要结局
MACE
时间窗: 1 year
MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death
次要结局
- Patient quality of life (QoL)(1 year)
- 6 Minute Walking Test(1 year)
- NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome(1 year)
研究者
Per Steinar Halvorsen
Consultant and research group leader
Oslo University Hospital