Predictors of T-wave oversensing study
Research type
Research Study
Full title
Predictors of T-wave oversensing: A case control study.
IRAS ID
150536
Contact name
David Wilson
Contact email
Sponsor organisation
University Hospitals Southampton NHS Foundation Trust
Research summary
The purpose of this study is to investigate the causes of T-wave oversensing (TWOS) in subcutaneous implantable cardioverter defibrillators (S-ICD).
Every year in Britain, tens of thousands of people die as a result of lethal arrhythmias. Implantable cardioverter-defibrillators (ICDs) are implanted in people who are at high risk of lethal arrhythmias. The ICD works by sensing, detecting and treating lethal arrhythmias. Subcutaneous ICDs (S-ICDs) have been developed to improve on the traditional transvenous ICD. TWOS occurs when the S-ICD double counts a single sensed beat resulting in a doubling of the sensed heart rate. This can result in an inappropriate shock (IAS) to the patient. IASs are painful and distressing for patients and occur at rate of 6% per annum in those with S-ICD.
In this study, we aim to indentify predictors of IAS from TWOS from group of patients in Southampton and Dudley by comparing clinical records of patients with S-ICD who have had IAS from TWOS (TWOS group) with those who haven’t (control group).
We also aim to compare the heart recordings (electrocardiograms (ECG)) of the TWOS and control group over a 24-hour period using a holter monitor and also during exercise using an exercise treadmill test.
Cost relating to inappropropriate shocks due to TWOS will be calculated. Quality of life will be assessed using the Florida Shock Anxiety Scale tool.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/0197
Date of REC Opinion
18 Jun 2014
REC opinion
Further Information Favourable Opinion