Heart Two
Research type
Research Study
Full title
Haemodialysis associated changes in R:T ratio and T wave morphology: an observational study of S-ICD sensing
IRAS ID
233591
Contact name
Paul Roberts
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Implantable cardioverter defibrillators (ICD) are used to prevent sudden cardiac death in patients who are felt to be at risk of developing life threatening heart rhythms. They work by continuously analysing a patient’s heart tracing and shocking the heart if required. An entirely subcutaneous ICD (S-ICD) is now available. It has been demonstrated to be both safe and effective. \n\nHaemodialysis patients are known to be at high risk of sudden cardiac death. They could potentially benefit tremendously from an S-ICD as unlike traditional defibrillators they are not placed within the heart or veins. This is important as haemodialysis places patients at high risk of infections in the bloodstream and also produces high pressures in the venous system, which can complicate the use of traditional defibrillators.\n\nThe S-ICD determines whether a patient is in an abnormal rhythm by performing an analysis of that patient’s ECG morphology. T wave shape and R:T ratio are important to the device. These parameter are expected to vary in a haemodialysis patient due to changes in fluid and salt concentrations around the time of their dialysis.\n\nThis study seeks to quantify the changes in T wave morphology and R:T ratio by recording the heart tracings of patients undergoing dialysis. The study further seeks to assess the suitability of haemodialysis patients for S-ICD implantation and to compare the changes observed with a control cohort receiving diuretic therapy alone (not haemodialysis). Finally the study will assess a novel S-ICD sensing algorithm using an S-ICD simulator to assess the recorded heart tracings. \n\n\n\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0623
Date of REC Opinion
30 Nov 2017
REC opinion
Favourable Opinion