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