Study data from the Sorin-sponsored CLEAR (Clinical Evaluation on Advanced Resynchronisation) trial has shown significant improvement in heart failure patientsâ response to cardiac resynchronisation therapy with the company's SonR automatic CRT optimisation system.
SonR is designed to provide weekly automatic optimisation during patientâs daily activities as an alternative to in-clinic manual echocardiography-based device settings. The system consists of a dedicated sensor embedded in the tip of a pacing lead implanted with the CRT device. The technology allows direct measurement of real-time cardiac contractility and uses this haemodynamic signal to optimise the deviceâs parameters for each individual patient at rest and exercise.
The CLEAR study, a prospective, multicentre, single-blind, randomised study conducted in 51 centres in eight European countries, enrolled 238 patients with severe HF (New York Heart Association (NYHA) functional class III and IV and a left ventricular ejection fraction (LVEF) <35 per cent. study results at one year showed that with sonrâs regular automatic optimisation of the deviceâs atrio-ventricular and inter-ventricular delays, 76 cent patients were classified as improved, compared 62 in group standard crt programming (p =0.0285).
The SonR sensor measures patientâs cardiac muscle vibrations related to the first heart sound and transmits the data to the CRT-D device which uses them to determine the best settings for the patient. The measurements correspond to LVdP/dtmax, the gold standard for assessing left ventricular contractility, a key indicator of cardiac performance.