Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll thirty participants. Participants will be monitored daily at home for a period of 30 days. Each day, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's weight will also be taken each day.

Inclusion criteria

• Age 18 years or older.
• NYHA Class III HF.
• Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
• Patient is characterized by at least one of the following:

• CardioMEMS implanted within the previous 90 days
• Received treatment with intravenous diuretics within the previous 30 days
• Received dose escalation of oral diuretics at least twice within the previous 30 days
• Patient is able to sit upright for BIS measurements.
• Patient provides written informed consent and authorization to use and disclose health information.

Exclusion criteria

• Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion.
• Patient has a clinical condition that would not allow them to complete the study.
• Patient is pregnant or lactating.
• Patient has nephrotic syndrome or nephrosis.
• Patient has estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
• Patient has been diagnosed with lymphedema.
• Patient has chronic liver failure or cirrhosis.
• Patient has a moderate or large pleural effusion as seen on chest X-ray.
• Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days.
• Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator).
• Patient has an amputation of a limb.