Enrolling by invitation NCT07158450
Novel On-body Evaluation of Cardiac Health for Oncology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiotoxicity, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study
Overview
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.
Primary outcome measures
- Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates [Time frame: From baseline through study completion (up to 6 months) at each paired assessment]
Secondary outcome measures (1)
- Clinical accuracy of wearable-derived LVEF compared with echocardiography [Time frame: From baseline through study completion (up to 6 months) at each paired assessment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Colorado Heart and Vascular — Golden
- Clearwater Cardiovascular Consultants — Clearwater
- Midwest Cardiovascular Institute — Naperville
- Cardiovascular Institute of the South — Houma
- Strong Memorial Hospital — Rochester
- Cardiology Consultants of Philadelphia — Yardley
- Stern Cardiovascular Center — Germantown
Identifiers
NCT: NCT07158450 · SKR-LVEF-001