Results of St Jude Medical’s MultiPoint Pacing investigational device exemption clinical study have been presented during a late-breaking clinical trial session at the Heart Rhythm Society’s (HRS) 37th annual scientific sessions.
The prospective, multicentre, randomised, double-blinded non-inferiority St Jude Medical MPP investigational device exemption study met its primary endpoints of safety and efficacy, and additional analyses indicated a positive impact of MultiPoint Pacing programming on patient response to therapy.
The study included more than 500 patients at 49 centres who were all implanted with a quadripolar pacing device. In the first three months of the trial, all patients received biventricular pacing. Thereafter, patients were randomised to either standard biventricular pacing or MultiPoint Pacing programming for an additional six months of follow-up. Those first three months without MultiPoint Pacing programming turned on allowed the investigators to determine the patient’s response or non-response to cardiac resynchronisation therapy. Patients’ responder status was assessed at three and nine months using the Clinical Composite Score.
The primary safety endpoint was met with a 93.2% freedom from system-related complications. The primary efficacy endpoint was met by demonstrating non-inferiority of response rate in the MultiPoint Pacing technology group compared to the biventricular pacing group at nine months compared to three months. Additional analyses demonstrated the ability of MultiPoint Pacing technology to achieve an 87% response rate in patients with optimal program settings.
“Due to the complex nature of their cardiac disease and electrical conduction patterns, it is not possible to determine which of our heart failure patients will be non-responders to traditional cardiac resynchronisation therapy. The MultiPoint Pacing technology provides additional options for treating these difficult to manage patients and as this study shows, we continue to learn more about which program settings are most effective,” says Gery Tomassoni, primary investigator of this study and director of electrophysiology at Baptist Health Lexington in Lexington, Kentucky.
“We know that up to one-third of patients do not respond to traditional cardiac resynchronisation therapy. A growing body of clinical evidence, including data from this IDE study, shows that MultiPoint Pacing can enhance the response to CRT for heart failure patients whose devices are appropriately programmed,” says Mark Carlson, vice president of global clinical affairs and chief medical officer at St Jude Medical. “We will continue to study and improve the response of cardiac resynchronisation therapy and look forward to the results of our MORE CRT-MPP study that just completed enrolment.”
The MultiPoint Pacing technology, featured on the Quadra Assura MP cardiac resynchronisation therapy defibrillator and the Quadra Allure MP cardiac resynchronisation therapy-pacemaker recently received US Food and Drug Administration (FDA) approval and launched in markets throughout the US.