A Study to Determine the Feasibility of Wireless Electrocardiography
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|ClinicalTrials.gov Identifier: NCT02162394|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 25, 2017
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Premature Atrial and Ventricular Beats Conduction Defects Normal Sinus Rhythm||Device: Observational ambulatory ECG monitoring|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Study to Determine the Feasibility of Wireless Electrocardiography|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||January 2016|
|Referred for Holter monitoring||
Device: Observational ambulatory ECG monitoring
- Percent of 8 second ECG strips of sufficient quality for visual diagnosis [ Time Frame: 3 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162394
|United States, New York|
|Lenox Hill Hospital|
|New York, New York, United States, 10075|