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

NYU Langone Health

Status: Completed

Conditions: Cardiac Electrical Function

Treatments: Device: 12 Lead Glove

Study type: Observational

Funder types: Other

Identifiers

NCT01218334

06-777

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 3 patient groups

1

Description:

Cardiac Inpatient

2

Description:

Cardiac Outpatient

3

Description:

Cardiac Clinic Patient

Treatment:

Device: 12 Lead Glove