A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess Cardiac Electrical Function
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/11/2017 |
| Start Date: | June 2008 |
| End Date: | February 2012 |
A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function
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.
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.
Inclusion Criteria:
1. Preop assessment for elective cardiac catheterization or EP procedure.
2. Outpatient cardiology appointments.
3. Inpatients admitted with a cardiac diagnosis
Exclusion Criteria:
1. Age less than 18.
2. Skin breakdown.
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