Arrythmia Clinical Trial
Official title:
SANSA Electrocardiogram (ECG) Validation Study
| 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 |
| Verified date | May 2024 |
| Source | Huxley Medical, Inc. |
| Contact | Jill Fricke |
| Phone | 949-310-4697 |
| jfricke[@]huxleymed.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Comparison of diagnostic Electrocardiogram (ECG) signals
| 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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Huxley Medical, Inc. |
| 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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