NCT04221958

Brief Summary

This study aims to confirm a scientific concept that superficially placed electrocardiogram (ECG) leads may be compared to one another to help determine positioning. If proven to be effective, this could offer a more non-invasive means of positioning using superficial ECG tracings.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
5 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

January 6, 2020

Last Update Submit

April 30, 2025

Conditions

Electrocardiogram

Outcome Measures

Primary Outcomes (1)

  • ECG Tracing

    ECG tracing for each electrode will be recorded in voltage per unit of time.

    Approximately 30 minutes

Study Arms (1)

Electrocardiogram (ECG) Mapping

Participants will have 10 superficial electrode-patches placed on their chest in two vertical columns of 5 electrode-patches. The channels V1-V5 will be connected to one of the columns. The channel V6 will be connected to each of the electrode-patches in the second column ad recordings will be taken for approximately 2 minutes on each electrode-patch. ECG readings will be recorded.

Device: Electrocardiogram

Interventions

ElectrocardiogramDEVICE

An electrocardiogram measures the electrical activity of the heartbeat. This "intervention" will be used on healthy adult volunteers whom are part of the staff at the institution.

Electrocardiogram (ECG) Mapping

Eligibility Criteria

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

The population of participants include healthy volunteers from the research/administrative/health care staff from the institution.

You may qualify if:

  • Adult volunteers from institution's staff
  • Age \>18 years

You may not qualify if:

  • \- Existing heart conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Med Ctr Line

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations

US(1)