Clinical Trial Studying AF

A clinical trial evaluating a cardiac plug to help prevent strokes in patients with Atrial Fibrillation (AF) was launched by cardiology researchers at the University of Texas Health Science Center at Houston (UTHealth) Medical School.

An estimated 2.7 million Americans suffer from AF which causes 20 percent of all ischemic strokes, the most common form of stroke. A person with AF is five times more likely to have a stroke.

AF the most common type of arrhythmia presents a problem with the rate or rhythm of the heartbeat caused by dysfunctional electrical activity. As a result, the heart can beat too fast, too slow, or irregularly. Blood can pool in the atria, causing an inadequate supply of blood to pump into the ventricles, the lower chambers.

According to Richard Smalling, M.D., Co-Investigator for the trial, “The most common blood thinners prescribed for AF are warfarin and dabigatran. The biggest drawback of warfarin is that patients need regular blood tests to check levels of the drug, which typically keep changing which means that cardiologists need to adjust the dosage to prevent dangerous bleeding.”    

To conduct the study, UTHealth cardiologists have implanted the first AMPLATZER™ Cardiac Plug (ACP) in a patient at the Memorial Hermann Heart & Vascular Institute at the University of Texas Medical Center. The study will determine if the transcatheter device is safe and effective in preventing blood clots from migrating into the bloodstream in patients with non-valvular AF who are at high risk for stroke.

The AMPLATZER plug a self-expanding device made from nitinol mesh is used to seal the left atrial appendage to minimize the chance of blood clots migrating into bloodstream. Patients usually only have a one night hospital stay.

The multiple site clinical trial will enroll between 400 and 3,000 patients. The trial is randomized with two patients receiving the device and one patient receiving traditional medical treatment using long-term, blood thinning medication.

For more information, call the Center for Advanced heart Failure at the Memorial Hermann Heart & Vascular Institute at the Texas Medical Center at (713) 704-4300