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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04352816
Other study ID # FO401218
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 9, 2019
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source University Hospitals Coventry and Warwickshire NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multi-centre observational cohort trial to identify Magnetocardiography (MCG) parameters in the prediction of future ICD therapy. To show a correlation between Arrhythmogenic features on MCG and future ICD therapies seen on ICD interrogation of patients at risk of SCD.


Description:

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Study Design


Intervention

Device:
Magnetocardiogram
Magnetocardiography (MCG) is a non-invasive, non-contact body-surface method which uses magnetometers to measure and map the magnetic fields generated by the electrical activity within the heart. It offers a better spatial resolution than an ECG recording and opens the possibility of detecting conduction characteristics consistent with arrhythmogenesis.9-15 The application of MCG has been limited by feasibility as devices up to now have been based on superconducting quantum interference devices (SQUID) with supercooled sensors. These machines were often operated in a shielded environment, to decrease magnetic field interference (noise) from electrical devices and other sources of magnetic fields. This was a major limiting factor in deploying these devices in a working environment especially considering, that most hospital wards will have numerous devices that can interfere with the device.

Locations

Country Name City State
United Kingdom University Hospital Coventry and Warwickshire NHS Trust Coventry West Midlands

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with features of heterogenous myocardial conduction (eg. late QRS signals, QT dispersion) and correlation with ventricular arrhythmias as reported by ICD interrogation We will remotely follow up participants who have had ICD and observe if they have had an ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up. We will the compare the MCG scans of participants who had shock with that of whom did not. 12-72 months
Secondary Exploring the correlation of MCG QRS fragmentation and current flow analysis with ICD therapies Outcome measures - ICD therapies: ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up.
MCG: QRS fragmentation as defined by waveform extrema and amplitude in normalised MCG waveform.
Current flow analysis is derived from MCG field maps and is perpendicular to the magnetic field.
12-72 months
Secondary Exploring the correlation between ECG parameters, Echo findings, MCG parameters and ICD therapies. Outcome measures - ICD therapies: ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up.
ECG parameters: QRS width
Echo parameters: Left Ventricular Ejection Fraction - categorised into participants with severely impaired systolic function (LVEF<35%) or those without (LVEF>35%)
MCG parameters: Features of heterogenous conduction (eg. late QRS signals, QT dispersion)
12-72 months
Secondary Correlation of MCG parameters with Left ventricular ejection fraction (LVEF) LVEF as determined by Echo or CMRI expressed as % change in LV volume during cardiac cycle
MCG parameters: Features of heterogenous conduction (eg. late QRS signals, QT dispersion)
Baseline
Secondary Analysis of the SF-36 quality of life questionnaire results Evaluate the responses to a SF-36 quality of life questionnaire to document the tolerability of ICD implantation and therapy.
Comparisons will be made between responses from those participants who have received therapy from their device and those who haven't and between those participants who have a primary or secondary indication for their device.
12 month follow up
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