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| Name | Class |
|---|---|
| Coala Life, Inc | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coala Heart Monitor | Device | ECG monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| New-onset arrhythmias | Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient compliance | Patient compliance with at least two daily recordings. | Week 8 |
| Patient self-reported health | Patient self-reported health assessed by KCCQ. |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed heart failure patients > 18 years of age from heart failure clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Kjøbek Lamberts, MD, PhD | Contact | +4522434186 | morten.kjoebek.lamberts@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Herlev & Gentofte Hospital | Recruiting | Copenhagen | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 months |
| Patient-reported outcomes | Patients' response to technology and experience using the device assessed by self-developed questionnaire. | 3 months |
| Assessing recordings | Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed. | 3 months |
| Subsequent prescriptions | Through linkage with nationwide health care databases, subsequent prescription patterns of diuretics and antithrombotic medication in patients with and without atrial fibrillation. | 3 years |
| Subsequent implantations | Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation. | 3 years |
| Subsequent readmissions | Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation. | 3 years |
| All-cause mortality | Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation. | 3 years |
| Cardiovascular mortality | Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation. | 3 years |
| Admissions for worsening heart failure | Through linkage with nationwide health care databases, and admission for worsening heart failure in patients with and without atrial fibrillation. | 3 years |