Cardiac Electrical Function
Conditions
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.
Interventions
DEVICE12 Lead Glove
Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine
Sponsors
NYU Langone Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of Hand ECG to standard ECG with physician over-read | 1 year |
Countries
United States
Outcome results
None listed