Patients with chronic heart failure in NYHA functional class III with 1 or more HF hospitalization (>6 hours admission or need of iv diuretics) in the past 12 months.
Conditions
Interventions
CardioMEMS PA monitoring
Sponsors
Erasmus University Medical Center
Voorwaardelijke toelating tot basispakket zorg 2019 procedure via Zorginstituut en VWS.
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Written informed consent obtained from subject aged >18 years 2. Diagnosis of chronic heart failure in NYHA functional Class III with at least 1 HF hospitalization within 12 months of baseline visit 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 study and able to comply to the daily readings *) definition of HF according the ESC guidelines 2016 for HFrEF HFmEF and HFpEF
Exclusion criteria
Exclusion criteria: 1. Subjects with an active infection 2. Subjects with history of recurrent (>1) pulmonary embolism or deep vein thrombosis 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 valve(s) 7. Subjects with known pulmonary arterial hypertension (WHO category 1 or 4/5) were PA pressure are most likely not responsive to cardiac treatment. 8. Subjects is scheduled for or likely to undergo heart-transplantation or VAD within 6 months of baseline visit 9. Subjects with known coagulation disorders or allergy to aspirin, and/or clopidogrel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (KCCQ questionnaires) | — |
Secondary
| Measure | Time frame |
|---|---|
| HF hospitalizations Cost effectiveness | — |
Contacts
Public ContactJ.J. Brugts
Department of Cardiology, Erasmus MC Thoraxcenter
Outcome results
None listed