To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.
Male or female ≥ 18 years old.
Symptomatic HF (NYHA III) with recent heart failure admission in the previous year (12 months). OR
Patient with at least one ER visit or unplanned HF clinic requiring iv diuretics within 12 months will be eligible if they have in addition a N-terminal pro-BNP (NT-proBNP) level > 800pg/ml at screening AND NYHA Class II on diuretics (furosemide ≥ 40mg qd), III or ambulatory IV.
HF with reduced or preserved EF of at least 3 months duration.
Recent cardiovascular event: Acute coronary syndrome (STEMI/NSTEMI; a small rise in the troponin level would be expected in this population and is not a contraindication for enrolment); Percutaneous Coronary Intervention (PCI), new cardiac rhythm management (CRM) device (pacemaker, ICD and CRT), CRM system revision, lead extraction or cardiac or other major surgery or transient ischemic attack or stroke within 2 months (3 months of stabilization after CRT or cardiac surgery);
Scheduled cardiac surgery;
History of pulmonary embolism or recurrent deep vein thrombosis;
Persistent NYHA Class IV and ACC/AHA HF Stage D, patients implanted with a ventricular assist device (VAD), or patients listed for cardiac transplantation and likely to be transplanted within 12 months;
Parallel
CardioMems
Devicenovel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System
first occurrence of any component of the composite event
acute decompensated heart failure requiring emergency department consultation
Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
unplanned intravenous heart failure therapy in an outpatient clinic
Number of Participants with hospital admission for heart failure
hospital admission for heart failure
Number of Participants with cardiovascular (CV) death
cardiovascular (CV) death
Time to the first occurrence of the individual components of the primary endpoint
Acute decompensated heart failure that requires emergency department consultation and/or unplanned intravenous heart failure therapy in an outpatient clinic
Number of Participants with CV death
CV death
Change in Quality of life
Quality of life questionnaire
Change in functional capacity between baseline and 12-months
NYHA functional class (Kansas city cardiomyopathy questionnaire)
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