PACE HERE
Research type
Research Study
Full title
The Effect of Leadless Pacemaker Position On The R: T Ratio: An Observational Study of S-ICD Sensing
IRAS ID
285743
Contact name
Mohamed ElRefai
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Subcutaneous Implantable Cardioverter Defibrillators (S-ICD) are used to prevent sudden cardiac death in patients considered 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. The S-ICD determines whether a patient is in an abnormal rhythm by performing an analysis of that patient's ECG trace. T wave shape and R:T ratio are important to the device. If it starts counting T waves (resting heart waves) as contractions of heart muscle, as well as the real contractions, the resulting double counting is called 'T wave oversensing', which may lead to an inappropriate shock.
S-ICD's do not provide anti tachycardia pacing (ATP) as a treatment option, which is a painless alternative to a shock. Implant of a leadless pacemaker would provide this treatment option. Research into communication between both devices and T wave oversensing has not been conducted in humans.
This study would aim to recruit 50 participants from one site, Southampton General Hospital, to wear a 7 lead Holter monitor (small portable ECG recorder) during their clinically scheduled procedure. The procedure may look at the electrical systems of the heart, provide heat/freezing treatment to stop a heart rhythm disturbance in the electrical circuits or implant of a cardiac device. During the procedure, the right ventricle will be paced for 10 beats in four specific areas. Post procedure, holter data will be analysed to determine the effect of the position in the ventricle on the paced beat configuration, T wave oversensing and R:T ratio. The holter mimics what an S-ICD would 'see', whilst pacing occurs in the four areas of the right ventricle. Pacing simulates potential positions a leadless pacemaker may be implanted to minimise the risk of T wave oversensing.
Participants would be enrolled for 1 day only.Summary of Results
: Pacing in the heart alters the parameters that are important for the sensing function of the subcutaneous defibrillaotrs significantly in most patients, theoretically increasing the risk for inappropriate shocks by the defibrillators.
Tailored programming for both devices is important for concomitant use of Leadless pacemakers and subcutaneous cardiac defibrillators.
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REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0366
Date of REC Opinion
29 Sep 2020
REC opinion
Further Information Favourable Opinion