Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723355
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2021-01-19
Brief Title:
A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
A Comparative Study of the Findings of Dynamic Electrocardiography Holter System Using the an Innovative 3-lead Wireless Water Resistant Device and a Conventional Device
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias Newer Holter monitors may provide some advantages over the more traditional ones This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device
Detailed Description:
The 24-hour ambulatory electrocardiography commonly known as Holter monitoring is a diagnostic method to correlate clinical symptoms with cardiac arrhythmias The Holter monitor records electrical signals from the heart using electrodes attached to the chest which are connected via cables to a digital recorder In addition to the device to record the cardiac electrical signals the Holter system also has a software for review and analysis of the record The software of the Holter system has an integrated automatic analysis process to detect different sorts of heart beats rhythms etc which are then validated by a technician and a physician The success of the automatic analysis depends of the quality of the captured electrical signals which are dependent on the appropriate attachment of the electrodescables to the patient body Therefore inappropriately attached electrodescables can result in electromagnetic disturbance that can interfere with the ECG signal resulting in a very noisy record that is hard to be analysed
Newer Holter systems that eliminate the cables and attach the recorder directly to the electrodes positioned in the patients chest might reduce the electromagnetic disturbance in the ECG signal capture and therefore improve the quality of the exam
This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device
Newer Holter systems that eliminate the cables and attach the recorder directly to the electrodes positioned in the patients chest might reduce the electromagnetic disturbance in the ECG signal capture and therefore improve the quality of the exam
This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None