05.14.13
Sorin Group, a Milan, Italy-based medical device company focused on cardiovascular disease, has been given conditional approval from the U.S. Food and Drug Administration (FDA) for its investigational device exemption (IDE) application and clinical trial protocol for Respond CRT. The trial will study the safety and effectiveness of the Sonr cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. Respond CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial.
Cardiac resynchronization therapy is a therapy that delivers timely electrical pulses to the chambers of the heart. This allows the heart to beat in a more coordinated and synchronized manner.
The Sonr sensor is designed to measure patients’ cardiac muscle vibrations related to the first heart sound. These real-time measurements are transmitted to the CRT-D device, which uses them to determine the best settings for the patient. The system is designed to automatically optimize to adapt to the patient’s changing condition every week. Sonr measurements correspond to LVdP/dtmax, the gold standard for assessing left ventricular contractility, a key indicator of cardiac performance. The Sonr CRT optimization system received CE mark in October 2011 and currently is one of the most widely used CRT systems in Europe. According to Sorin, Sonr is the only CRT hemodynamic sensor-based optimization system that is designed to automatically optimize patients every week and, importantly, while the patient is active, providing real-life optimization.
The system is comprised of the Sonr hemodynamic sensor embedded in the Sonrtip atrial pacing lead and the Paradym RF Sonr CRT-D device, which includes an algorithm designed to automatically optimize the patient’s atrioventricular delay and interventricular delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. 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.
“The Sonr system with its innovative sensor is a significant CRT engineering advancement,” said Jagmeet P. Singh, M.D., Ph.D., director of the cardiac resynchronization program at Massachusetts General Hospital in Boston, Mass., and U.S. principal investigator of the Respond CRT trial. “Respond CRT is the largest trial to date studying this system, and thus we hope to gain valuable evidence further demonstrating that the Sonr system offers a significant clinical advancement and can improve heart failure symptoms for a larger number of patients.”
The Respond study is designed to build upon Sorin’s earlier clinical experience with its first-generation Sonr device, as shown by the Clear clinical study described in the September 2012 issue of the peer-reviewed journal Europace. The published results from the Clear clinical study showed that at 12 months, 76 percent of patients receiving Sonr CRT optimization were classified as improved, compared with 62 percent in the group of patients with standard CRT programming.
President of Sorin’s CRM business unit Stefano Di Lullo called the Sonr system “an excellent example of [Sorin’s] commitment to develop unique solutions to improve therapy effectiveness. He went on to say, “Clinical results from international studies of Sonr have been very positive, and we hope to extend this base of robust evidence with the Respond CRT trial and launch this innovative CRT system in the United States to benefit many of the 5 million Americans with heart failure.”
The company anticipates that the trial will start enrolling U.S. patients in the first half of this year. The trial will enroll more than 1,000 patients at more than 100 investigational sites worldwide, with
approximately one-third of patients in the United States.
Effectiveness will be evaluated by the number of patients within each treatment group that responds to CRT therapy by an improvement in New York Health Association class, a scale by which heart failure severity is measured; or an improvement in quality of life at 12 months without experiencing a heart failure-related adverse event or death. Patients will be followed for 24 months.
Sorin Group’s U.S. offices are located in Arvada, Colo.
Cardiac resynchronization therapy is a therapy that delivers timely electrical pulses to the chambers of the heart. This allows the heart to beat in a more coordinated and synchronized manner.
Paradym RF Sonr CRT-D device. Image courtesy of Sorin Group. |
The system is comprised of the Sonr hemodynamic sensor embedded in the Sonrtip atrial pacing lead and the Paradym RF Sonr CRT-D device, which includes an algorithm designed to automatically optimize the patient’s atrioventricular delay and interventricular delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. 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.
“The Sonr system with its innovative sensor is a significant CRT engineering advancement,” said Jagmeet P. Singh, M.D., Ph.D., director of the cardiac resynchronization program at Massachusetts General Hospital in Boston, Mass., and U.S. principal investigator of the Respond CRT trial. “Respond CRT is the largest trial to date studying this system, and thus we hope to gain valuable evidence further demonstrating that the Sonr system offers a significant clinical advancement and can improve heart failure symptoms for a larger number of patients.”
The Respond study is designed to build upon Sorin’s earlier clinical experience with its first-generation Sonr device, as shown by the Clear clinical study described in the September 2012 issue of the peer-reviewed journal Europace. The published results from the Clear clinical study showed that at 12 months, 76 percent of patients receiving Sonr CRT optimization were classified as improved, compared with 62 percent in the group of patients with standard CRT programming.
President of Sorin’s CRM business unit Stefano Di Lullo called the Sonr system “an excellent example of [Sorin’s] commitment to develop unique solutions to improve therapy effectiveness. He went on to say, “Clinical results from international studies of Sonr have been very positive, and we hope to extend this base of robust evidence with the Respond CRT trial and launch this innovative CRT system in the United States to benefit many of the 5 million Americans with heart failure.”
The company anticipates that the trial will start enrolling U.S. patients in the first half of this year. The trial will enroll more than 1,000 patients at more than 100 investigational sites worldwide, with
approximately one-third of patients in the United States.
Effectiveness will be evaluated by the number of patients within each treatment group that responds to CRT therapy by an improvement in New York Health Association class, a scale by which heart failure severity is measured; or an improvement in quality of life at 12 months without experiencing a heart failure-related adverse event or death. Patients will be followed for 24 months.
Sorin Group’s U.S. offices are located in Arvada, Colo.