The study population for this clinical investigation (pilot feasibility study) is advanced heart failure NYHA class III patients with dyspnea upon mild physical activity, or NYHA class IV patients who are refractory to advanced heart failure management and scheduled for semi-elective or elective LVAD implantation (INTERMACS class 2-5). The CardioMEMS device has been studied in chronic heart failure patients but not in LVAD patients. With permission of the company, we study this new patient grou
Conditions
Interventions
Hemodynamic guidance by CardioMEMS PA sensor
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Signed Informed Consent Form (ICF) • Age ≥18 years • LVEF = 1.2 m2 and chest circumference, at the axillary level, of less than 65 inches if BMI >35 kg/m2 • Females of child bearing age must agree to use adequate contraception and at inclusion negative pregnancy test
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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, • unable to tolerate right heart catheterization • Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients’ health status • 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 LVAS management • patients with mechanical right heart valves, • INTERMACS 1 emergency LVAD implantations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effectiveness and potential of the hybrid construction between CardioMEMS PA senseor and HeartMate-III LVAD device The number of HF hospitalizations | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-hoc analyses will be performed to study pulmonary hypertension and its potential reversibility during LVAD treatment. Additionally, we will study heart rate detection with cardioMEMS during LVAD treatment and the incidence of VTs. Additionally, we will study renal function and urinary measurements during follow-up with LVAD treatment in relation to PA pressure, and Rv function. | — |
Contacts
Public ContactJ.J. Brugts
Department of Cardiology, Erasmus MC Thoraxcenter
Outcome results
None listed