Enrollment Begins In St.Jude’s Next-Generation Quadra Pacing Study

In short

St. Jude Medical, Inc.has commenced enrollment in its MultiPoint™ Pacing clinical study to build upon its first-to-market Quadripolar Pacing System. Patients will be implanted with the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D) and Quartet® lead to assess pacing in multiple locations in the heart.

Background

Cardiac resynchronization therapy can be delivered by an implantable cardioverter defibrillator (ICD) to resynchronize the beating of the ventricles, which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood.

MultiPoint pacing provides the ability to deliver two left ventricular (LV) pacing pulses, either simultaneously or sequentially, rather than the standard single pulse for each pacing cycle. This may be beneficial in further increasing the responder rates to CRT because it may capture a larger area of the cardiac anatomy by engaging areas around already damaged tissue.

The MultiPoint Pacing study will evaluate benefits of CRT in heart failure patients, such as improved hemodynamics and cardiac function.The prospective, randomized, double-blind, multi-center clinical study will enroll more than 500 patients at 50 centers in the U.S. Implanted patients will receive the single pacing pulse available with the existing quadripolar systems for the first three months. After three months, patients will be classified as being responders or non-responders to single-point CRT pacing and then will be randomized to either a single or multi-point pacing group. Patients will be monitored for an additional six months, at which time responder rates will be compared between patients receiving MultiPoint pacing and single point pacing

Physician comments

“The MultiPoint Pacing trial is a study of patients who may not receive benefit or are unresponsive to standard CRT single-point pacing. We are evaluating whether MPP can increase the potential for a successful CRT outcome by pacing in multiple locations in the heart,” said Gery Tomassoni, M.D., director of electrophysiology at Baptist Health Lexington in Lexington, Ky.

Company comments

“The Quadra Assura MP device builds upon the robust platform available with the current St. Jude Medical quadripolar technology and provides additional tools that may improve the CRT responder rate even further,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Implantable Electronic Systems Division. “This study represents our commitment to investing in product innovation and clinical evidence to ensure an increasing number of patients continue to respond to, and appropriately benefit from, CRT.”

Sourc: St.Jude Medical, Inc.