Clinical Trial: AMPLATZER™ Cardiac Plug prevents clot migration
The first three patients in the United States to receive the AMPLATZER™ Cardiac Plug (ACP) as part of a nationwide clinical trial received the device at the Providence Hospital Heart Institute this spring. The ACP device is designed to prevent blood clots from migrating out of the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who have a high risk for stroke. Patients with untreated atrial fibrillation are four to five times more likely to have a stroke; 80 to 90 percent of clots originate in the left atrial appendage.
The AMPLATZER™ device was introduced in 2008 and is currently available in Europe and Asia. A self-expanding occlusion device, it is constructed from nitinol mesh. Using general anesthetic, we deliver the device via catheter through the groin to the LAA. Fluoroscopy and ultrasound assist in positioning. The procedure is non-invasive and patients are typically discharged the next day.
Once in place, the umbrella-shaped device completely seals the LAA at its opening and prevents clots from dislodging and migrating into the bloodstream, causing stroke or clot in a limb. Most patients who receive the implant can stop all anticoagulant drugs within 45 days.
We expect to recruit participants over the next two years. For additional study information, visit http://clinicaltrials.gov and search for "Amplatzer cardiac plug clinical trial."
To refer a patient, call the Providence Hospital Heart Institute, (248) 849-2000, or Jean Kelly, RN, research coordinator, (248) 849-3369. A study nurse will perform initial patient screening over the phone and schedule potential participants for an evaluation with Dr. Machado.