NCT04112576

Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF). To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function

Detailed description

This is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with HFpEF or HFrEF. Approximately 70% of participants will have HFpEF and 30% will have HFrEF. There will be one study visit per participant. The study visit includes device placement and data collection during postural changes. Echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. The device will then be removed.

Conditions

• Heart Failure, Systolic
• Heart Failure, Diastolic

Interventions

Type	Name	Description
DEVICE	Wearable cardiac monitor	Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Timeline

• Start date: 2020-07-23
• Primary completion: 2022-05-11
• Completion: 2022-05-11
• First posted: 2019-10-02
• Last updated: 2023-04-07

Locations

3 sites across 3 countries: United States, Singapore, Taiwan