Assessment of paravalvular leak after transcatheter aortic valve implantation by hemodynamic measurements and cardiac MRI - Appose trial

Radboud Universitair Medisch Centrum0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•1. Patients must be >18 years old.
•2. Written informed consent is obtained from all patients.
•3. Severe aortic valve stenosis is defined as: jet velocity greater than 4.0m/s
•or Doppler Velocity index <0.25 or an initial aortic valve area (AVA) of <=
•1.0cm² (indexed EOA<=06cm²/m²) as measured by trans thoracic echocardiography
•<6months prior to inclusion
•4. Patients have symptomatic aortic stenosis, as demonstrated by NYHA
•functional class 2 or greater or other symptoms of aortic stenosis (e.g.
•syncope or angina in the absence of coronary artery disease).
•5. Surgical risk is deemed high or intermediate by STS score or by documented
•Heart-team agreement due to frailty or co-morbidities.
•6. The aortic annulus diameter as measured by ECG-triggered CT-scanning <
•6months prior to inclusion meets the ranges indicated in the instructions for
•7. The access artery diameters (femoral or subclavian) as measured by
•CT-scanning < 6 months prior to inclusion meet the ranges indicated in the
•instruction for use
•8. There are no contra-indications for and patient is willing to undergo
•cardiac MRI at discharge to 30 days after TAVI.

•1. Patient is unwilling or unable to comply with study-required follow-up
•evaluations
•2. There is evidence of a myocardial infarction within 30 days to index
•3. The presence of severe mitral regurgitation or stenosis
•4. The presence of pre-existing prosthetic cardiac device, valve or prosthetic
•ring in any position
•5. Left ventricular ejection fraction (LVEF) less than 30%
•6. Untreated significant coronary artery disease requiring revascularization
•7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
•suggesting active endocarditis
•8. The patient is hemodynamically unstable, requiring inotropic or vasopressive
•and / or mechanical support
•9. The presence of pulmonary edema or intra venous diuretics to stabilize heart
•failure at index procedure
•10. Renal insufficiency, defined as a serum creatinin greater than 250umol/l or
•end-stage renal disease requiring dialysis
•11. Morbid obesity, defined as a BMI >=40
•12. A life expectancy of less than one year.

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