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NCT06414447 Clinical Trial

Electrocardiogram (ECG) Validation Study

Arrythmia Clinical Trial

Official title:
SANSA Electrocardiogram (ECG) Validation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06414447
Other study ID # CP-10000
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date July 2024

Study information
Verified date May 2024
Source Huxley Medical, Inc.
Contact Jill Fricke
Phone 949-310-4697
Email jfricke@huxleymed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of diagnostic Electrocardiogram (ECG) signals

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Huxley Medical
diagnostic

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Huxley Medical, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of the diagnostic Electrocardiogram (ECG) signal quality of the P, QRS and T wave deflections of the Sansa device to a reference standard Holter monitor 3 months
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