Clinical trial · Observational
Novel On-body Evaluation of Cardiac Health for Oncology
Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study
NCT07158450CI-TRIAL-00112196NOECHOenrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Healthy
- description
- No known or suspected cardiac disease
- label
- Borderline LVEF
- description
- Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction
- label
- Reduced LVEF
- description
- Known diagnosis of reduced left ventricular ejection fraction
Primary outcomes (1)
- measure
- Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates
- timeFrame
- From baseline through study completion (up to 6 months) at each paired assessment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.