Italian medical device firm Sorin Group has initiated patient enrolment in the TRIUMPH-CRT clinical trial in Europe with the world’s first triple-site ventricular (Tri-V) pacing CRT-D device.
The trial is designed to evaluate the benefits of individually optimised Tri-V pacing over standard biventricular pacing in patients with a non-left bundle branch block (LBBB) morphology.
During the trial, the company will use its Paradym CRT-D Tri-V device, which paces ventricles at three different locations. A special connector in the device allows the use of three ventricular leads without the need for any separate adaptor.
University of Rennes Hôpital Pontchaillou and the study principal investigator professor Jean-Claude Daubert said: "There is a need to find alternative CRT solutions for patients that have a poor response to the standard therapy.
"The TRIUMPH-CRT trial focuses specifically on non-LBBB heart failure patients, and we want to demonstrate that individually optimised Tri-V pacing will help to significantly improve their ventricular function.
"In addition, using a specially designed Tri-V device with a dedicated connector will streamline the implant procedure and limit further complications."
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Approximately 216 patients in Europe will be enrolled in the multicentre, international, prospective and randomised TRIUMPH-CRT trial.
The trial’s primary endpoint is to show that individually optimised triple-site pacing (Tri-V pacing) is superior to standard biventricular pacing in reverse ventricular remodelling.
The endpoint will be evaluated by measuring the left ventricle end-systolic volume (LVESV) by echocardiography at 12 months post implant, while echocardiographic findings will also be assessed by an independent core laboratory.
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."