HEMOdynamic guidance with PA-sensor CardioMEMS in patients with an left ventricular assist device (LVAD) - HEMO-VAD pilot

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•-Signed Informed Consent Form (ICF)
•-Age *18 years
•-LVEF <25%
•-NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV with INTERMACS classes 2-5
•-Scheduled or intended for LVAD implantation within 1 month
•-Body surface Area ><= 1.2 m2 and chest circumference, at the axillary level, of less than 65 inches if BMI >35 kg/m2

•*No written informed consent
•*Patients with contra-indications for the PA pressure sensor device, which will include active infection, a history of deep vein thrombosis or recurrent pulmonary embolism,
•*Patients unable to tolerate right heart catheterization
•*Intolerance to anticoagulant or antiplatelet therapies
•*Patients with a known coagulation disorder or hypersensitivity to aspirin.
•*History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (>1 episode) pulmonary embolism and/or deep vein thrombosis
•*Fixed pulmonary hypertension with a most recent PVR * 8 Wood units that is unresponsive to pharmacologic intervention (which makes CardioMEMS sensor no additive value)
•*History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
•*Serum creatinine * 221 umol/L or eGFR below 25 or the need for chronic renal replacement therapy
•*Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management
•*Patients with mechanical right heart valves,
•*INTERMACS 1 emergency LVAD implantations.

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