Surface ECG Mapping

Surface ECG Mapping in Healthy Adult Volunteers

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.

Study Overview

• Status: Withdrawn
• Conditions: Electrocardiogram
• Intervention / Treatment: Device: Electrocardiogram

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Existing heart conditions

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG Tracing	ECG tracing for each electrode will be recorded in voltage per unit of time.	Approximately 30 minutes

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 54619

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No