Italian Cardiovascular technologies company Sorin Group, says it has reached the target enrollment for RESPOND CRT, an Investigational Device Exemption (IDE) clinical trial. The trial studies the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with severe heart failure.
Sorin’s SonR system features a unique hemodynamic sensor which assesses the patient’s left ventricular contractility to automatically optimize the atrioventricular (AV) and interventricular (VV) settings – with the goal of improving the patient’s response to CRT. The SonR hemodynamic sensor is designed to uniquely measure a patient’s cardiac muscle vibrations which reflect the left ventricular contractility, a key indicator of cardiac performance. These real-time measurements are transmitted to the CRT implantable device which determines the best settings for the patient and automatically optimizes to adapt to the patient’s changing condition.
The RESPOND CRT study is designed to build upon Sorin’s CLEAR clinical study which evaluated the SonR CRT optimization system in 238 European patients. In that study, 12 month results showed 76 percent of patients receiving SonR CRT optimization to be classified as improved, compared with 62 percent in the control patient group followed with standard practice (p=0.0285).
It was late March 2013 when Sorin gained FDA’s approval to start its RESPOND CRT IDE study, since which time it has enrolled a total of 1,039 patients in Europe, USA and Australia. The patients have been randomized to receive either SonR weekly automatic optimization or manual echocardiography optimization at pre-discharge visit and are followed in a double-blinded fashion. The primary effectiveness endpoint will be evaluated at the 12-month follow-up. Results are expected in spring 2016.
“I am very impressed by the interest of the investigators in the RESPOND CRT trial,” said Prof. Josep Brugada, Hospital Clinic, University of Barcelona, Spain, principal study investigator. “Thanks to their support we have been able to achieve the enrollments ahead of schedule. I am pleased with the continued progress of this very large study aiming to further demonstrate that heart failure patients can benefit from SonR automatic optimization. I look forward to the one-year follow-up results”.
“RESPOND CRT is a key trial to further demonstrate the clinical benefits of our innovative SonR technology”, said Stefano Di Lullo, President CRM Business Unit, Sorin Group. “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 million3 Americans suffering from heart failure”.
Source: Sorin Group, SpA., Business Wire