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.
Study Type
OBSERVATIONAL
Enrollment
395
Hull and East Yorkshire Hospitals NHS Trust
Cottingham, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Imperial college Healthcare NHS Trust
London, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Regional Restitution Instability Index (R2I2), the mean of the standard deviation of the residuals from the mean gradients for each ECG lead across a range of diastolic intervals, will be determined from an EP study carried out at ICD implant.
* For each lead of the surface ECG, the QTpeak will be plotted as a function of TpeakQ, and gradients were fitted by using 40ms overlapping least squares linear segments as described previously by Taggart et al. \[9\]. For each lead, in each 40 ms segment, the difference of the gradient from the mean gradient in that 40 ms segment will be calculated. The mean of the standard deviation of these values will be taken as the R2I2. * An R2I2 cut-off of 1.03 (no units) will partition the study population into high and low risk groups.
Time frame: 12 - 36 months
Peak ECG Restitution Slope (PERS), calculated as the peak restitution curve slope taken as a mean across the 12 ECG leads .
A PERS cut-off of 1.21 (no units) will partition the study population into high and low risk groups.
Time frame: 12 - 36 months
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