Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction—UK multicentre collaboration

IntroductionThe purpose of this study is to assess the ability of two new ECG markers (Regional Repolarisation Instability Index (R2I2) and Peak Electrical Restitution Slope) to predict sudden cardiac death (SCD) or ventricular arrhythmia (VA) events in patients with ischaemic cardiomyopathy undergoing implantation of an implantable cardioverter defibrillator for primary prevention indication.Methods and analysisMulticentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction is a prospective, open label, single blinded, multicentre observational study to establish the efficacy of two ECG biomarkers in predicting VA risk. 440 participants with ischaemic cardiomyopathy undergoing routine first time implantable cardioverter-defibrillator (ICD) implantation for primary prevention indication are currently being recruited. An electrophysiological (EP) study is performed using a non-invasive programmed electrical stimulation protocol via the implanted device. All participants will undergo the EP study hence no randomisation is required. Participants will be followed up over a minimum of 18 months and up to 3 years. The first patient was recruited in August 2016 and the study will be completed at the final participant follow-up visit. The primary endpoint is ventricular fibrillation or sustained ventricular tachycardia >200 beats/min as recorded by the ICD. The secondary endpoint is SCD. Analysis of the ECG data obtained during the EP study will be performed by the core lab where blinding of patient health status and endpoints will be maintained.Ethics and disseminationEthical approval has been granted by Research Ethics Committees Northern Ireland (reference no. 16/NI/0069). The results will inform the design of a definitive Randomised Controlled Trial (RCT). Dissemination will include peer reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries.Trial registration numberNCT03022487.

Successful Identification of and Discrimination Between Atrial and Ventricular Arrhythmia with the Aid of Pacing and Defibrillator Devices

The presence of supraventricular tachycardia is the leading cause of inappropriate shock in ICD recipients, and it can be a significant cause of morbidity, psychological distress and worsened clinical outcome. Modern pacing and ICD systems offer a number of discriminators that are integrated into algorithms to differentiate sustained ventricular tachycardia from supraventricular tachycardia. These algorithms can be adapted and optimised for each individual patient to ensure that only those arrhythmias that need treatment through the use of an ICD, are actually treated. This review summarises the single- and dual-chamber discriminators that can be used in the detection and classification of tachyarrhythmias.