Validation of Electrical Ventricular Activation Patterns Using CIPS
Research type
Research Study
Full title
Assessment of the cardiac isochrone positioning system in the evaluation of ventricular activation patterns in heart failure patients with cardiac resynchronisation devices.
IRAS ID
215644
Contact name
Francisco Leyva
Contact email
Sponsor organisation
University Hospital Birmingham NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
The development of specialized pacemakers has revolutionized the management of heart failure over the past two decades. These devices improve the timing of electrical activation within the failing heart and have been shown to result in significant improvements in symptoms and overall heart function. However, approximately one-third of patients fail to respond to this therapy. The reasons for this are not completely understood, but may be partly attributed to the non-optimal placement of pacemaker leads within the heart. Improved understanding of how electrical signals travel in the heart could, one day, help to improve how these pacemakers are implanted and/or improve the response rates.
Aims
In this noninvasive study, we seek to assess the feasibility and accuracy of a new computer-based algorithm, termed the Cardiac Isochrone Positioning System (CIPS), which can generate three-dimensional electrical maps from routinely performed clinical data.
What we will do
We will recruit 50 patients diagnosed with heart failure from a single hospital Centre. Those selected will have previously undergone pacemaker implantation and cross-sectional imaging studies as part of the their routine clinical management.
Recruited participants will undergo temporary adjustment of pacemaker settings, performed remotely using standard equipment employed during routine clinical care. This will enable temporary adjustment of the site of stimulation of the heart, which will last less than 30-40 seconds in total duration. A simple tracing of the electrical signals of the heart, termed an ECG (electrocardiogram) will be undertaken by placing standard recording electrodes onto the body surface. This will then be translated into three-dimensional electrical tracings of the heart using computer software.
Duration
It is anticipated that subjects will require only one hospital attendance for all study-related tasks to be completed and following this, their participation in the research will conclude.
Summary of Results
This study looked at how a novel tool, non-invasive electrocardiographic imaging technique, can help assess how well the heart's ventricles are working together during a procedure to implant a cardiac resynchronization therapy (CRT) device. The goal was to see if improvements in how the ventricles synchronize during the procedure are linked to better heart function.
We tested this on patients receiving CRT devices by measuring the heart's electrical activity before and after the device was implanted. The results showed that the CRT device significantly improved how the heart’s ventricles synchronized during the procedure.
This suggests that measuring synchronization during the procedure using this novel tool could help predict long-term improvements in heart function.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0435
Date of REC Opinion
7 Nov 2017
REC opinion
Further Information Favourable Opinion