Sorin Group Completes Enrollment in Respond CRT IDE Trial

Devicemaker Sorin Group said last week it completed enrolment in its Respond CRT investigational device exemption clinical trial. The trial will evaluate the safety and effectiveness of the SonR cardiac resynchronization therapy optimization system in patients with severe heart failure.

The SonR hemodynamic sensor is designed to measure a patient’s cardiac muscle vibrations that reflect the left ventricular contractility, a key indicator of cardiac performance. The measurements are transmitted to the CRT implantable device which determines the best settings for the patient, helping to improve their response to the treatment, Sorin said.

The company enrolled 1,039 patients in the U.S., Europe and Australia. The patients are randomized to receive either SonR weekly automatic optimization or manual echocardiography optimization at pre-discharge visit. The main efficacy endpoint will be evaluated at 12 months, with results expected in spring 2016, the devicemaker said.

The study hopes to build upon Sorin’s CLEAR clinical trial which evaluated the SonR CRT optimization system in 238 European patients. Results from that trial showed that 76 percent of the patients receiving SonR therapy improved compared to 62 percent in the control group who received standard care. — Kellen Owings

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