Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction — MINERVA  

Ischemic Cardiomyopathy Clinical Trial

Official title: Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction (MINERVA)

Status Completed

Clinical Trial Summary

This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG and will be correlated with event rates to establish their effectiveness in predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years, which is how long the study is funded for. This study is not randomised as all study patients will be receiving the EP study performed at baseline. A minimum of 440 patients will be recruited to document event data at standard clinical ICD follow up intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will be performed by a nominated researcher who will not have details of patient health status.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• Ischemic Cardiomyopathy
• Ventricular Arrythmia

• NCT number: NCT03022487
• Study type: Observational
• Source: University of Leicester
• Status: Completed
• Start date: July 8, 2016
• Completion date: September 30, 2022