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Clinical Trials/NCT01218334
NCT01218334
Completed
Not Applicable

A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function

NYU Langone Health1 site in 1 country300 target enrollmentJune 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Electrical Function
Sponsor
NYU Langone Health
Enrollment
300
Locations
1
Primary Endpoint
comparison of Hand ECG to standard ECG with physician over-read
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
February 2012
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Preop assessment for elective cardiac catheterization or EP procedure.
  • Outpatient cardiology appointments.
  • Inpatients admitted with a cardiac diagnosis

Exclusion Criteria

  • Age less than
  • Skin breakdown.

Outcomes

Primary Outcomes

comparison of Hand ECG to standard ECG with physician over-read

Time Frame: 1 year

Study Sites (1)

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