NCT04537104

Remote Monitoring in Patients With Heart Failure

Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective cohort study with consecutive enrollment of newly diagnosed heart failure patients, investigating the prevalence and types of arrhythmias in this high-risk population using non-invasive remote monitoring with the Coala Heart Monitor. Participants are scheduled to use the Coala Heart Monitor twice daily or during symptoms (e.g. syncope, presyncope, palpitations, chest discomfort, or shortness of breath) to record a thumb and chest ECG over 3 months. Patient compliance with the recordings, self-reported health, response to technology, and experience using the device will additionally be assessed by self-developed questionnaires and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Coala Heart Monitor	ECG monitoring

Timeline

• Start date: 2020-09-24
• Primary completion: 2021-09-01
• Completion: 2023-09-01
• First posted: 2020-09-03
• Last updated: 2021-01-14

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study