NCT03022487

Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 395 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Arrythmia
• Ischemic Cardiomyopathy

Timeline

• Start date: 2016-07-08
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2017-01-16
• Last updated: 2024-01-05

Locations

8 sites across 1 country: United Kingdom