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| Name | Class |
|---|---|
| University of Rochester | OTHER |
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The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | No known or suspected cardiac disease | ||
| Borderline LVEF | Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction | ||
| Reduced LVEF | Known diagnosis of reduced left ventricular ejection fraction |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates | The primary analysis will compute the correlation coefficient (r) between wearable-derived model estimates of LVEF and transthoracic echocardiography-derived LVEF in the Hold-Out Test Set. The prespecified performance target is r > 0.70. | From baseline through study completion (up to 6 months) at each paired assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical accuracy of wearable-derived LVEF compared with echocardiography | Proportion of predictions within ±5 percentage points of TTE-derived LVEF in the Hold-Out Test Set. Error metrics will be calculated as Mean Absolute Error (MAE) between wearable-derived and TTE-derived LVEF. Differences across subgroups will be tested with ANOVA or Kruskal-Wallis as appropriate. Prespecified performance target: MAE ≤ 5 percentage points. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (≥18 years) recruited from participating cardiology clinics. Participants are assigned to one of three cohorts by transthoracic echocardiography (TTE): Healthy (no known structural heart disease; LVEF ≥ 55%), Borderline/Possibly reduced LVEF (LVEF 40-54% or clinical concern for decline), and Reduced LVEF (LVEF < 40%). The population is intended to span the full spectrum of systolic function for model training and evaluation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Heart and Vascular | Golden | Colorado | 80401 | United States | ||
| Clearwater Cardiovascular Consultants |
Individual participant data will not be shared due to proprietary device algorithms and consent restrictions.
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| From baseline through study completion (up to 6 months) at each paired assessment |
| Clearwater |
| Florida |
| 33756 |
| United States |
| Midwest Cardiovascular Institute | Naperville | Illinois | 60540 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Strong Memorial Hospital | Rochester | New York | 14642 | United States |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | United States |
| Stern Cardiovascular Center | Germantown | Tennessee | 38138 | United States |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |