Wireless Handheld 8-lead ECG Device Performance in Heart Patients (Rapid Rhythm)
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|ClinicalTrials.gov Identifier: NCT03501836|
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Heart Murmurs||Device: Rapid Rhythm Handheld 8-lead ECG Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Performance Evaluation Study of a Six Electrode (8 Lead) Wireless Handheld ECG Recording Device With Four Lead Chest Extension Versus Conventional 12-lead ECG in Heart Patients|
|Actual Study Start Date :||January 24, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Rapid Rhythm Handheld 8-lead ECG Device
Participants will have measurements taken with the 8 lead ECG system, which will be compared to the conventional standard care 12 lead ECG.
Device: Rapid Rhythm Handheld 8-lead ECG Device
We want to explore whether using 6 electrodes on the chest (as in the Rapid Rhythm Handheld 8-lead ECG device) can give the same diagnostic result to the standard 10 electrode (12-lead) ECG, which uses 6 chest electrodes plus 4 electrodes on the arms and legs.
To do this we need to compare measurements taken with the 6 electrode (8 lead) study device to those taken with the gold-standard 10 electrode (12 lead) method.
We want to find out whether the new equipment can detect the same heart rhythms as the standard method, so that ECG measurements might be made more quickly and easily in the future.
- Capabilities of an 8 lead ECG system (Rapid Rhythm) - normal ECGs [ Time Frame: 18 months ]The percentage of ECGs where a normal control ECG is matched by a normal RR ECG.
- Capabilities of an 8 lead ECG system (Rapid Rhythm) - abnormal ECGs [ Time Frame: 18 months ]The percentage of ECGs where abnormalities of the control ECG are matched by similar abnormalities of the RR ECG.
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): NCT03501836
|Contact: Sarah Mackiefirstname.lastname@example.org|
|Manchester University NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M13 9WL|
|Contact: Sarah Mackie +441612763336 email@example.com|
|Principal Investigator: Fozia Ahmed|