Cardiotoxicity, Heart Failure
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Skribe Medical
University of Rochester
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Undergoing an echocardiogram irrespective of participation in this study * Willing and able to provide informed consent prior to any study-related activity
Exclusion criteria
* Have a documented allergy to potential tissue contacting system materials * Have any condition that would cause inaccurate TTE measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates | From baseline through study completion (up to 6 months) at each paired assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical accuracy of wearable-derived LVEF compared with echocardiography | From baseline through study completion (up to 6 months) at each paired assessment | 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. |
Countries
United States
Outcome results
None listed