NCT06414447

Brief Summary

Comparison of diagnostic Electrocardiogram (ECG) signals

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 7, 2024

Last Update Submit

May 9, 2024

Conditions

Arrythmia

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Huxley MedicalDIAGNOSTIC_TEST

diagnostic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects willing to participate in an ECG diagnostic evaluation

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jill Fricke

CONTACT

949-310-4697jfricke@huxleymed.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 16, 2024

Study Start

May 1, 2024

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05