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This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects |
| ||
| Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I |
| ||
| Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I |
| ||
| Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Software | Device | Observation only |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk | Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate subject compliance and experience using the Pyxida System | Outcomes of subject post-study survey | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System | Correlation between in-clinic 6-minute walk test (6MWT) measures of exercise tolerance and ambulatory electrocardiogram (ECG) | 14 days |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Single-center study of asymptomatic healthy subjects and subjects with HF risk factors and no more than mild to moderate symptoms
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| Name | Affiliation | Role |
|---|---|---|
| Michael Koren, MD | Jacksonville Center For Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002312 | Cardiomyopathy, Hypertrophic |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
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| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006332 | Cardiomegaly |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |