## Protocol Section
### Identification Module
**NCT ID:** NCT06414447

**Brief Title:** Electrocardiogram (ECG) Validation Study

**Official Title:** SANSA Electrocardiogram (ECG) Validation Study

#### Organization Study ID Info
**ID:** CP-10000
#### Organization
**Class:** INDUSTRY
**Full Name:** Huxley Medical, Inc.
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Huxley Medical, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** True

### Description Module

**Brief Summary:** Comparison of diagnostic Electrocardiogram (ECG) signals

### Conditions Module

**Conditions:**

- Arrythmia

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** diagnostic

**Name:** Huxley Medical

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

**Time Frame:** 3 months

### Eligibility Module

**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)

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** subjects willing to participate in an ECG diagnostic evaluation

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jfricke@huxleymed.com

**Name:** Jill Fricke

**Phone:** 949-310-4697

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: HIGH

- As Found: Arrhythmia

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001145

- Term: Arrhythmias, Cardiac

### Misc Info Module

- Version Holder: 2024-05-31
