Evaluation of a Novel, Non-Invasive Approach to Estimating Pulmonary Artery Pressure as an Alternative Method for Tracking Heart Failure Status
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Comparing Vivio measurements to CardioMEMS measurements over time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects over the age of
- •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.
排除标准
- •Open skin lesions at the site of Vivio application / examination.
- •Inability to obtain brachial artery blood pressure.
结局指标
主要结局
Comparing Vivio measurements to CardioMEMS measurements over time
时间窗: From enrollment to the end of participation at 30-90 days
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.
次要结局
- Assessment of KCCQ-12 Scores(From time of enrollment to 12 months after completion of participant Vivio use)
- KCCQ-12 and Ventric HF Score Comparison(From time of enrollment to end of participation at 30-90 days)
- Assessment of Ventric HF Scores(From time of enrollment to end of participation at 30-90 days)
- Vivio and CardioMEMS measurements related to SAEs and other HF related events(From time of enrollment to 2 years after completion of participant Vivio use)