Electrocardiogram (ECG) Validation Study

NCT ID: NCT06414447

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-07-31

Brief Summary

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Comparison of diagnostic Electrocardiogram (ECG) signals

Detailed Description

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Conditions

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Arrythmia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Huxley Medical

diagnostic

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huxley Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jill Fricke

Role: CONTACT

949-310-4697

Other Identifiers

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CP-10000

Identifier Type: -

Identifier Source: org_study_id

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