An observational study in Cardiotoxicity and Heart Failure, sponsored by Skribe Medical. Enrolling by invitation at 11 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Skribe Medical · Observational
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.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 111 across 124 observational studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →This is the only study on the registry with Skribe Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No known or suspected cardiac disease
Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction
Known diagnosis of reduced left ventricular ejection fraction
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.
Time frame: From baseline through study completion (up to 6 months) at each paired assessment
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.
Time frame: From baseline through study completion (up to 6 months) at each paired assessment
Plan to share: No — Individual participant data will not be shared due to proprietary device algorithms and consent restrictions.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Mar 2027, 17 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: primary completion Sep 2026 → Mar 2027 and completion Sep 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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