Medical device giant St. Jude Medical (NYSE:STJ) enrolled the 1st patient in the pivotal phase of its Amplatzer Cardiac Plug clinical trial, which will compare the company’s Amplatzer device to long-term treatment with blood-thinning medication.
The ACP trial in total will enroll at least 400 and no more than 3,000 patients at up to 90 sites in the U.S. and Canada to determine whether Amplatzer is safe and effective for preventing blood clots from migrating out of the heart’s left atrial appendage.
The 1st patient was enrolled at the Providence Hospital Heart Institute in Southfield, Mich. by electrophysiology director Dr. Christian Machado.
"Patients with untreated atrial fibrillation are 4 to 5 times more likely to have a stroke, which greatly increases their risk of disability or death," Machado said in prepared remarks. "We are excited to contribute research that may help expand treatment options for patients."
Earlier this year St. Jude’s Amplatzer Amulet catheter-based left atrial appendage closure device, a descendant of the original Amplatzer cardiac plug, won CE Mark approval in the European Union.
