Hemodynamic Monitoring with the CardioMEMS PA sensor and Quality of Life in Patients with Chronic Heart Failure: The MONITOR HF Trial - MONITOR HF Trial

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 340 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1. Written informed consent obtained from subject aged >18 years
•2. Diagnosis of NYHA-Class III heart failure with at least 1 (additional) HF
•hospitalization within 12 months of baseline visit (independent of EF %)
•3. Subjects with reduced EF (HFrEF) should be treated according to National and
•International (ESC) guidelines for optimal or maximum tolerated doses of HF
•medication and evaluated for ICD or CRT-D therapy if indicated.
•4. Subjects with a BMI <=35. Subjects with BMI >35 will require their chest
•circumference to be measured at the axillary level <65 inches (related to
•distance of the sensor)
•5. Subjects willing and able to comply with the follow-up requirements of the

•1. Subjects with an active infection
•2. Subjects with history of recurrent (>1) pulmonary embolism or deep vein
•3. Subjects who have had a major cardiovascular event (e.g., myocardial
•infarction, open heart surgery, stroke) within 2 months
•4. Subjects with Cardiac Resynchronization Device (CRT) implanted <3 months
•prior to enrolment and implantation of the sensor (in order to avoid
•manipulation of lead)
•5. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min (obtained within
•2 weeks of the baseline visit), refractory to diuretic therapy or on chronic
•renal dialysis
•6. Subjects with complex congenital heart disease or mechanical right heart
•7. Subjects is scheduled for or likely to undergo heart-transplantation or VAD
•within 6 months of baseline visit
•8. Subjects with known coagulation disorders or allergy to aspirin, and/or
•clopidogrel.

发起方