St Jude Medical announced the first enrolments in the company’s LEADLESS Pacemaker Observational Study evaluating the Nanostim leadless pacing technology. The Nanostim pacemaker received CE mark in 2013, and post-approval implants have occurred in the UK, Germany, Italy, Czech Republic, France, Spain, and The Netherlands.
The LEADLESS Pacemaker Observational Study is a prospective, multicentre, post-market clinical study designed to build additional evidence to support the safety profile of the Nanostim leadless pacemaker in patients indicated for ventricular single chamber pacing. It will provide long-term data about the Nanostim leadless pacemaker and will seek to demonstrate additional information about the long-term performance of the device. The trial is the largest to study leadless pacemakers, and will enrol approximately 1,000 patients in approximately 100 centres in Europe.
“This large European study was uniquely designed to help assess the health benefits associated with the Nanostim leadless pacemaker,” says Johannes Sperzel, principal investigator in the study and head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany. “We look forward to adding to the already strong clinical evidence supporting the benefits to patients receiving this revolutionary technology.”
Initial results from the LEADLESS study, a prospective, single-arm, multicentre study evaluating patients with the Nanostim leadless pacemaker, were presented last year and demonstrated overall device performance comparable to conventional pacemakers. Total implant procedure times averaged 28 minutes.
The first US implant in the LEADLESS II pivotal trial, designed to evaluate the Nanostim leadless pacemaker for US Food and Drug Administration (FDA) approval, took place in February 2014. The trial is being conducted under an investigational device exemption from the FDA, and will enrol approximately 670 patients at up to 60 centres worldwide, with up to 50 sites in USA.