Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program
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.
• Minimum technological knowledge either with a smartphone or iPAD for use of the self-management application, including access to internet.
• Anatomical criteria
‣ PA branch diameter between 7 mm - 15 mm
⁃ For BMI \>35, distance from patient's back to target PA\<10cm