Right ventricle remodeling after pulmonary valve replacement and percutaneous pulmonary valve insertion, a functional and histopathological assessment. - RV-REPAIR

niversitair Medisch Centrum Utrecht0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Grown-up congenital heart disease patients with pulmonary insufficiency and/or stenosis and an indication for pulmonary valve replacement or percutaneous pulmonary valve insertion according to local GUCH team advise (based on current ESC GUCH guidelines). Also subjects who do not meet the indication criteria for valve replacement are eligible to participate in the study. They will form a conservative cohort.

•- Individual is younger than 18 years of age.
•- Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
•- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia).
•- Individual is pregnant, nursing or planning to be pregnant.
•- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
•- Individual is currently enrolled in an investigational drug or device trial.
•- Individual with any contraindications for MRI:
•a. The presence of implanted non-MRI-compatible cardiac pacemaker or implanted cardioverter defibrillator.
•b. Implanted electronic devices like cochlear implants and nerve stimulators.
•c. Patients who are unable to fit into the bore of the magnet.
•d. Claustrophobia

发起方

niversitair Medisch Centrum Utrecht