On 8 March, St Jude Medical announced the first patient implant in a new pivotal trial evaluating the company’s Amplatzer Cardiac Plug for the prevention of stroke.
The ACP (Amplatzer Cardiac Plug) clinical trial is designed to determine if the Amplatzer device is safe and effective in preventing thrombus from migrating out of the left atrial appendage in patients with non-valvular atrial fibrillation who have a high risk for stroke.
The ACP trial is a prospective, randomised, multicentre clinical study with an adaptive trial design that will enrol no fewer than 400 and no more than 3,000 patients at up to 90 sites in the USA and Canada. The trial compares the safety and efficacy of the Amplatzer device to traditional medical treatment using long-term, blood-thinning medication.
Christian Machado, director of electrophysiology at the Providence Hospital Heart Institute, Southfield, USA, and investigator in the study, performed the first implant in the pivotal phase of the trial. The procedure was assisted by Thomas Forbes, a paediatric interventional cardiologist who is also an investigator in the study.
“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. Dr Forbes and I consider the ACP trial an important study as we look for ways to reduce this risk,” said Machado. “We are excited to contribute research that may help expand treatment options for patients.”
A company release stated that each ACP trial study site will have physicians who specialise in electrophysiology and interventional cardiology forming a collaboration between the two specialties.
“The current standard of care for the prevention of stroke is warfarin or other oral blood-thinning medications that can be difficult for some people to tolerate, and may carry a risk of serious complications, such as bleeding,” said James Hermiller, an interventional cardiologist from St Vincent Hospital in Indianapolis. USA, and ACP trial investigator. “As physicians, we are always looking for new ways to best treat our patients. 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.”
According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the USA an estimated US$53.9 billion in health care services, medications and missed days of work. Approximately 87% of all strokes are ischaemic. Atrial fibrillation is responsible for approximately 20% of ischaemic strokes, and about one-third of atrial fibrillation patients will have a stroke in their lifetime if not treated appropriately.
“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 USA,” said Frank J Callaghan, president of the St Jude Medical Cardiovascular and Ablation Technologies Division. “The ACP trial is another example of significant investment by St Jude Medical to develop landmark clinical evidence. This trial will help us understand the long-term benefits of left atrial appendage occlusion therapy for lowering the risk of stroke in atrial fibrillation patients and potentially improve their quality of life.”
Earlier this year, St Jude Medical received CE mark approval and launched the Amplatzer Amulet Left Atrial Appendage Occluder. Considered a next-generation occlusion device, the Amplatzer Amulet design was driven by feedback from physicians who have been implanting the Amplatzer Cardiac Plug in Europe since 2008.
The Amulet occluder is built with a longer lobe and waist than previous versions to allow for easier placement. The end screw is flush with the disc to create a smooth surface within the left atrium, and the larger disc diametre offers increased orifice coverage. The Amplatzer Amulet device is offered in eight sizes to accommodate varying anatomies. Additionally, the device is pre-loaded into the delivery catheter, which simplifies device preparation and ultimately streamlines the entire procedure for the physician.
The Amplatzer Cardiac Plug device is currently not approved for use in the USA. The ACP trial is conducted under an investigational device exemption from the US Food and Drug Administration (FDA).