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Sorin begins TRIUMPH-CRT clinical trial with Paradym CRT-D Tri-V device

Medical device firm Sorin Group has stated the TRIUMPH-CRT clinical trial in Europe, which is designed to assess the benefits of individually optimized Tri-V pacing over standard biventricular pacing in patients with a non-Left Bundle Branch Block (LBBB) morphology.

The company will carry out the trial using its Paradym CRT-D Tri-V device, which paces the ventricles at three different locations.

The study’s principal investigator professor Jean-Claude Daubert said: "The TRIUMPH-CRT trial focuses specifically on non-LBBB heart failure patients, and we want to demonstrate that individually."

The study is a multicenter, international, prospective and randomized trial that will enroll up to 216 patients in Europe.

According to the firm, the primary endpoint of the study is to show that individually optimized triple-site pacing (Tri-V pacing) is superior to standard biventricular pacing in reverse ventricular remodeling.

The endpoint will be evaluated through measuring the left Ventricle End-Systolic Volume (LVESV) by echocardiography at 12 months post implant.

Sorin Group CRM business unit president Stefano Di Lullo said: "This landmark study has the potential to transform the standard of care for patients with heart failure who do not respond to CRT today and further reasserts our commitment to improving individual patient outcome."