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Remote Monitoring in Patients With Heart Failure

NCT04537104 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2021-01-14

No results posted yet for this study

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

Interventions

DEVICE

Coala Heart Monitor

ECG monitoring

Sponsors & Collaborators

  • Coala Life, Inc

    collaborator INDUSTRY

  • Herlev and Gentofte Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2021-09-01
Completion
2023-09-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537104 on ClinicalTrials.gov