A Study to Determine the Feasibility of Wireless Electrocardiography
The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.
The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.
|Cardiac Rhythm Disturbances Including: Atrial Fibrillation Premature Atrial and Ventricular Beats Conduction Defects Normal Sinus Rhythm||Device: Observational ambulatory ECG monitoring|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study to Determine the Feasibility of Wireless Electrocardiography|
- Percent of 8 second ECG strips of sufficient quality for visual diagnosis [ Time Frame: 3 hours ]
|Study Start Date:||June 2014|
|Study Completion Date:||January 2016|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Referred for Holter monitoring||Device: Observational ambulatory ECG monitoring|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02162394
|United States, New York|
|Lenox Hill Hospital|
|New York, New York, United States, 10075|