St. Jude Medical has implanted the first patient in a prospective, randomised, multi-centre study of its self-expanding occlusion device for the prevention of stroke in patients with non-valvular atrial fibrillation (AF).
Made with nitinol mesh, the Amplatzer Cardiac Plug (ACP) device is delivered via catheter to completely seal the left atrial appendage (LAA) at its opening and minimise blood clots from forming in the LAA and migrating into the bloodstream.
The pivotal, investigational device exemption trial, Amplatzer Cardiac Plug clinical trial (ACP trial), with an adaptive trial design will enrol 400 to 3,000 patients to compare the safety and efficacy of the device to traditional medical treatment that involves the use of long-term, blood-thinning medication like warfarin.
The trial will also help to understand the long-term benefits of LAA occlusion therapy for potentially improving the quality of life in AF patients, according to the company.
Providence Hospital Heart Institute electrophysiology director and study investigator Dr Christian Machado said, "Patients with untreated atrial fibrillation are four to five times more likely to have a stroke, which greatly increases their risk of disability or death."
St. Vincent Hospital interventional cardiologist and trial investigator Dr James Hermiller said, "We hope the ACP Trial will prove that we can reduce the risk of stroke in patients with atrial fibrillation through this minimally-invasive procedure."
St Jude Medical cardiovascular and ablation technologies division president Frank Callaghan said, "The AMPLATZER Cardiac Plug has shown great promise in international markets and we look forward to establishing the evidence required to make it available in the U.S."
The company said the ACP device is not approved for use in the US.
Image: Amplatzer Cardiac Plug (ACP) is designed to seal the left atrial appendage and minimises blood clots from forming and migrating into the bloodstream. Photo: Courtesy of St. Jude Medical, Inc.