Vivio At-Home Study

The purpose of the study is to examine the Vivio System's ability to track heart failure status in subjects, and compare the Vivio System's measurements to CardioMEMS measurements. Heart failure, which is a form of heart disease, is a condition where the heart does not pump enough blood through the body, resulting in the body not getting the amount of oxygen and nutrients it needs. This research study will collect data using CardioMEMS and the Vivio System in subjects over the age of 21 with a currently implanted, or scheduled to be implanted, CardioMEMS device. This group of individuals will provide researchers with important data because the measurements of their health information can be used to determine if the Vivio is as effective at tracking heart failure status as CardioMEMS. This research study is designed to develop new knowledge, and does not provide a direct benefit to study subjects

This is a prospective, comparative study for the evaluation of the Vivio System in estimating pulmonary artery pressure (PAP) compared to CardioMEMS measuring PAP to track heart failure (HF) status. This study will recruit adult participants based on the inclusion and exclusion criteria. A total of up to 500 participants will be enrolled at up to 20 sites across the United States. Participants will take Vivio and CardioMEMS measurements 2-4 times per week for a minimum of 30 days and a maximum of 90 days, and these measurements will be used to determine the Vivio System's ability to assess the changes in PAP over time.

After obtaining informed consent, a participant's demographics, physical traits, past medical history, and current medications will be documented. Participants will undergo an echocardiogram if they have not had one in the past 30 days before study enrollment. The participant will then have a blood draw, complete a KCCQ-12 Questionnaire and secondary questionnaire, take one Vivio measurement, and will be oriented to the study schedule, and trained on how to take Vivio measurements. During the participant's study enrollment, one successful Vivio measurement will be taken after completing one CardioMEMS measurement. One additional Vivio measurement will be taken if the participant enrolls in the study before CardioMEMS implantation. These measurements will be collected 2-4 times per week at the discretion of the participant's physician. After completion of assigned measurements, the participant will return the study equipment and complete a final questionnaire.

The proposed study is conducted according to CFR 812.2 in particular with regard to the device labeling, research done only after IRB approval and informed consent (21 CFR 50), with monitoring of the study and records kept as required by 21 CFR 56.