Date: 2014-10-31
Type of information: Completion of patient enrollment
phase:
Announcement: completion of patient enrollment
Company: Sorin (Italy)
Product: SonR cardiac resynchronization therapy
Action
mechanism: 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. The system automatically optimizes to adapt to the patient’s changing condition, providing real life optimization.
Disease: severe heart failure
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: RESPOND CRT is a pivotal multi-center, randomized, two-arm, double-blinded, prospective trial. 1,039 patients have been enrolled in this study in Europe, USA and Australia. The composite primary endpoint of death, HF re-hospitalization, NYHA class and quality of life will be evaluated at the 12-month follow-up. Mid to long-term effectiveness will be assessed at 18 and 24 months.
Latest
news: * On October, 31 2014, Sorin, a global medical device company and a leader in the treatment of cardiovascular diseases, announced that 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. RESPOND CRT 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. 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. The published CLEAR results showed that at 12 months 76 percent of patients receiving SonR CRT optimization were classified as improved, compared with 62 percent in the control patient group followed with standard practice (p=0.0285).
