Ventric Health, LLC
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…
Inclusion Criteria: * Adult subjects over the age of 21. * A CardioMEMS HF System implanted or scheduled to be implanted. * 70% or more signal strength from CardioMEMS at the time of enrollment. * Ability to successfully obtain a Vivio System measurement. * Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records up to 2 years after completion of the study. * Ability to understand and sign informed consent. Exclusion Criteria: * Open skin lesions at the site of Vivio application / examination. * Inability to obtain brach…
The Vivio measurement is taken after a CardioMEMS measurement