New Clinical Trial with World’s First Triple-Site Ventricular (Tri-V) Pacing CRT-D Device

Sorin Group has announced the start of patient enrollment in its TRIUMPH-CRT clinical trial in Europe. Why this matters is that it represents the first time ventricular pacing has been effected at three sites without the use of special adaptors.

Background

While standard CRT-D devices deliver ventricular pacing at two different ventricular sites, Sorin’s Paradym CRT-D Tri-V paces the ventricles at three different locations thanks to a dedciated connector that enables the use of three ventricular leads.

The TRIUMPH CRT study is designed to investigate the benefits of individually optimized Tri-V pacing over standard biventricular pacing in patients with a non-Left Bundle Branch Block (LBBB) morphology. Non-LBBB patients represent more than one third of CRT implants yet the evidence of a benefit for these patients is weak. The current European Guidelines consider non-LBBB as a Class II indication for which the decision to implant a CRT should be individualized based on other clinical criteria.

Poor response to Cardiac Resynchronization Therapy (CRT) in non-LBBB patients is suspected to be due to complex forms of electrical and mechanical dyssynchronies. Acute studies have suggested that non-LBBB patients may respond better to CRT if they are treated with Tri-V pacing rather than standard biventricular pacing. Hence Sorin’s efforts to confirm the theory.

The first patients enrolled in the study were successfully implanted at Hôpital Paris Saint-Joseph, Paris, in the electrophysiology department of Dr Serge Cazeau, M.D., cardiologist, and at Hospital Universitario y Politécnico La Fe, Valencia, Spain by Dr. Oscar Cano, M.D., electrophysiologist.

Company comments

“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,” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit.

Investigator comments

“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 optimized Tri-V pacing will help to significantly improve their ventricular function”, said Professor Jean-Claude Daubert, M.D., Hôpital Pontchaillou, University of Rennes, France, the study’s principal investigator. “In addition, using a specially designed Tri-V device with a dedicated connector will streamline the implant procedure and limit further complications”.

Source: Business Wire

Share your thoughts

Your email address will not be published. Required fields are marked *