The US Food and Drug Administration (FDA) has given conditional approval to Sorin for its investigational device exemption application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the SonR cardiac resynchronisation therapy (CRT) optimisation system in patients with advanced heart failure.
RESPOND CRT is a multicentre, randomised, two-arm, double-blinded, prospective trial that will enrol more than 1,000 patients in the United States and other countries. The primary effectiveness endpoint of the trial is the proportion of patients within each treatment group that responded to CRT therapy with an improvement in NYHA class or an improvement in quality of life at 12 months and did not experience a heart failure-related adverse event or death. Patients will be followed for 24 months.
According to a company release, the SonR optimisation system is comprised of the SonR haemodynamic sensor embedded in the SonRtip atrial pacing lead and the Paradym RF SonR CRT-D device, which includes a unique algorithm to automatically optimise the patient’s atrioventricular delay and interventricular (delay timing.
The company states that the SonR system is the first and only CRT haemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.