Electrocardiogram (ECG) Validation Study

Launched by HUXLEY MEDICAL, INC. · May 9, 2024

Keywords

ClinConnect Summary

The Electrocardiogram (ECG) Validation Study is a clinical trial that aims to compare different ECG signals to better understand how to diagnose arrhythmias, which are irregular heartbeats. This is important because accurate diagnosis can lead to better treatment for patients experiencing these heart issues. The trial is looking for participants who are at least 18 years old and can understand and sign consent forms. You will need to be willing to wear a device called the Sansa and a Holter monitor, which are tools that help track your heart's activity for 24 hours.

To be eligible, you should not have any significant chest deformities or injuries that would make it hard to place the sensors required for the study. Additionally, you should not have a pacemaker or be pregnant. If you decide to participate, you will be helping researchers find more effective ways to diagnose heart conditions, contributing to better care for future patients. Keep in mind that the trial is not yet recruiting, so it may take some time before it begins.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • 18 years of age of older
• • Able to read, understand, and sign informed consent documentation willing to wear the Sansa device and 3-lead or 5-lead Holter monitor simultaneously for 24- hours
• • In the opinion of the investigator, subject is willing to comply with the protocol
• • EXCLUSION CRITERIA
• • Noted deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would Interfere with sensor placement
• • broken or injured skin that would interfere with sensor placement, are known to experience adverse reactions to medical-grade adhesive
• • pacemaker dependent
• • females who are pregnant (self-reported)