Global medical device firm Sorin Group has completed enrolment in its Respond CRT, an investigational device exemption (IDE) clinical trial.
The trial will evaluate the safety and effectiveness of the new SonR cardiac resynchronisation therapy (CRT) optimisation system in patients with severe heart failure.
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SonR system features a haemodynamic sensor which evaluates the patient’s left ventricular contractility to automatically optimise the atrioventricular (AV) and interventricular (VV) settings, with the goal of improving the patient’s response to CRT.
In the Respond CRT trial, the company enrolled a total of 1,039 patients in Europe, US and Australia.
During the trial, patients were randomised to receive either SonR weekly automatic optimisation or manual echocardiography optimisation at a pre-discharge visit and are followed in a double-blinded fashion.
The trial’s primary effectiveness endpoint will be evaluated at the 12 month follow-up and results are expected to be reported in spring 2016.
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By GlobalDataThe trial is designed to build upon the company’s CLEAR clinical trial which evaluated the SonR CRT optimisation system in 238 European patients.
Results from the CLEAR trial showed that at 12 months 76% of patients receiving SonR CRT optimisation were classified as improved, compared to 62% in the control patient group followed with standard practice.
Sorin Group president CRM business unit Stefano Di Lullo said: "Respond CRT is a key trial to further demonstrate the clinical benefits of our innovative SonR technology.
"After SonR’s successful introduction in Europe, this study serves as a cornerstone to obtain FDA approval and to make this unique solution available to many of the five million Americans suffering from heart failure."
The SonR haemodynamic sensor is designed to measure a patient’s cardiac muscle vibrations, which reflect the left ventricular contractility, a key indicator of cardiac performance.
