Trial Number
549-25
Condition
Heart Failure
Participant Age Range
21 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“Evaluation of a Novel, non-Invasive Approach to Estimating Pulmonary Artery Pressure as an Alternative Method for Tracking Heart Failure Status.”
Researchers are studying whether the Vivio® System, a non-invasive arm cuff and ECG patch, can help track changes in heart failure by estimating pulmonary artery pressure and comparing the results to the implanted CardioMEMS™ Heart Failure System. Participants who have a CardioMEMS device (or are scheduled to receive one) will use both systems at home for approximately 30–90 days. The goal is to determine whether the Vivio System may provide a simpler, non-invasive way to monitor heart failure status over time. Participants will complete study visits, questionnaires, blood tests, and at-home measurements.