SonR ECHO - ICSY01
Research type
Research Study
Full title
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography.
IRAS ID
114323
Contact name
Guy Lloyd
Contact email
Sponsor organisation
SORIN CRM SAS
Research summary
The purpose of this study is to show that using SonR technology, which is a contractility sensor, to optimise device parameters increases the number of patients who respond to Cardiac Resynchronisation Therapy (CRT) compared to using Standard of Care (SoC) methods, which are those normally used by a hospital.
Not all patients respond to CRT. Since the large scale introduction of CRT, it has been observed that approximately 30-40% of patients don’t respond.
Response to CRT can be defined according to clinical or remodelling endpoints. A clinical endpoint is the improvement of a patient with a CRT device, based on criteria such as quality of life, heart failure events (needing hospitalization for stabilization) and exercise tolerance. A remodeling endpoint is a change in heart function which can be measured using echocardiography. Some measurements show the immediate impact of CRT on cardiac function; others show the impact of CRT after 1-3 months of therapy.
The number of non-responders can be reduced by optimizing the device programming. This study will also look at the effectiveness of the SonR System’s automatic optimisation compared to the SoC method of using Echocardiography by looking at how the filling of the Left Ventricle is affected.
No previous study has looked at the impact of CRT SonR optimisation on cardiac function as compared to that of SoC.
326 patients who are eligible for CRT-D implant will be enrolled in Europe and Canada. These implants will be performed within the NHS at specialized Cardiac Centres. Patients will be randomised into one of 2 groups, either receiving SonR optimization or SoC optimization. Patients will not know which group they have been assigned to. They will be seen at 2 months and 6 months after implant, at which times they will have specific measurements taken by echocardiography.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0029
Date of REC Opinion
5 Apr 2013
REC opinion
Further Information Favourable Opinion