Vivio At-Home Study

N/AEnrolling By InvitationNCT07730268

Ventric Health, LLC500 enrolled

Overview

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 brachial artery blood pressure.

Locations (4)

MemorialCare Long Beach Medical Center

Long Beach, California, United States

USC Keck School of Medicine

Los Angeles, California, United States

UC San Diego School of Medicine

San Diego, California, United States

Renown Regional Medical Center

Reno, Nevada, United States

Outcomes

Primary Outcomes

Comparing Vivio measurements to CardioMEMS measurements over time

To assess the longitudinal agreement between non-invasive hemodynamic signals collected using the Vivio System and pulmonary artery pressure (PAP) measurements obtained via the CardioMEMS HF System.

Time frame: From enrollment to the end of participation at 30-90 days

Secondary Outcomes

Assessment of KCCQ-12 Scores

To assess the association between the scores of the 12-question Kansas City Cardiomyopathy Questionnaire and the occurrence of heart failure hospitalization, the occurrence of HF-related events and/or all-cause mortality within 12 months after the conclusion of the Vivio/CardioMEMS monitoring period. The Kansas City Cardiomyopathy Questionnaire uses a 0 to 100 scale, where higher scores indicate better health and a higher quality of life with fewer limitations due to heart failure: ≥ 75: Good to excellent health status 50-74: Fair to good health status 25-49: Poor to fair health status \<25: Very poor health status

Time frame: From time of enrollment to 12 months after completion of participant Vivio use

KCCQ-12 and Ventric HF Score Comparison

Evaluating the degree of agreement and/or divergence between the non-validated Ventric Heart Failure Pro Questionnaire and the validated 12-question Kansas City Cardiomyopathy Questionnaire in capturing symptom burden, functional status, and health-related quality of life over time. The Kansas City Cardiomyopathy Questionnaire uses a 0 to 100 scale, where higher scores indicate better health and a higher quality of life with fewer limitations due to heart failure: ≥ 75: Good to excellent health status 50-74: Fair to good health status 25-49: Poor to fair health status \<25: Very poor health status. The Ventric Heart Failure Pro Questionnaire is a 12-question survey with a score range from 0-200 with a higher score indicating a higher risk of critical decompensation. The data from the study will be used to validate the questionnaire. We will compare the two questionnaires and assess the agreement and/or divergence between the scores and patient related outcomes.

Time frame: From time of enrollment to end of participation at 30-90 days

Assessment of Ventric HF Scores

Assessing the relationship between the Ventric Heart Failure Pro Questionnaire and the occurrence of HF-related events and/or hospitalization. The Ventric Heart Failure Pro Questionnaire is a 12 question survey with a score range from 0-200 with a higher score indicating a higher risk of critical decompensation. The data from the study will be used to validate the questionnaire.

Time frame: From time of enrollment to end of participation at 30-90 days

Vivio and CardioMEMS measurements related to SAEs and other HF related events

Evaluating the degree of agreement and/or divergence between non-invasive hemodynamic signals collected using the Vivio System and pulmonary artery pressure (PAP) measurements obtained via the CardioMEMS HF System prior to hospitalization (length of stay 24 hours or more) with the primary reason for admission being acute decompensated heart failure and intravenous administration of diuretic therapy, or an unscheduled or unplanned emergency department visit, or hospital outpatient observation visit with intravenous administration of diuretic therapy, counted only if it does not result in an inpatient admission of 24 hours or more.

Time frame: From time of enrollment to 2 years after completion of participant Vivio use