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A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess Cardiac Electrical Function

NCT01218334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2017-11-09

No results posted yet for this study

Summary

The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves. The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective cardiac catheterization or electrophysiology procedures; 2. patients coming for outpatient cardiology appointments; 3. Inpatients admitted with a cardiac diagnosis.

The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain the ECG.

Conditions

  • Cardiac Electrical Function

Interventions

DEVICE

12 Lead Glove

Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine

Sponsors & Collaborators

Principal Investigators

  • Anthony Aizer, MD · NYU Langone Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218334 on ClinicalTrials.gov