Researchers at the University of Texas Health Science Center at Houston (UTHealth) Medical School are launching a clinical trial to study the efficiency and effectiveness of cardiac plug in preventing the risk of ischemic stroke in patients with rhythm abnormalities like atrial fibrillation.
As part of this study, approximately 400 to 3000 participants will be enrolled in multiple centers. The study will be randomized,with every two patients receiving the AMPLATZER™ cardiac plug and one patient receiving traditional pharmacological therapy for blood clot prevention.
Details of the study:
The implantation of first cardiac plug (AMPLATZER™) was performed by cardiologists at the Texas Medical Center – Memorial Hermann Heart & Vascular Institute, back in September. As part of the study, researchers will analyze the effectiveness of cardiac plug in the prevention of blood clot migration via left atrial appendage in high risk population.
The associate chief of the medical division at the Center for Advanced Heart Failure at HVI and co-principal investigator of the study, Pranav Loyalka (who is also the associate professor in the Program of Advanced Heart Failure at the UTHealth Medical School) commented:
“Atrial fibrillation is a common problem and patients need blood thinners to help prevent stroke. AMPLATZER™ is one of the devices being studied that could give patients the ability to not take blood thinners.”
About Atrial Fibrillation:
The most frequently occurring cardiac rhythm abnormality or arrhythmia is Atrial fibrillation, which is caused by aberrations in the electrical activity of the heart. The rhythm is either too fast or too slow (but totally uncoordinated cardiac activity in between the atria and ventricles) that leads to pooling of blood in the atria and inadequate pumping of oxygenated blood to the periphery. Medical director and professor at UTHealth Medical School – Complex Arrhythmia Center and HVI, Dr. Ramesh Hariharan, suggested that the primary site of 90% blood clots is left atrial appendage in the setting of untreated or poorly managed atrial fibrillation.
In the United States alone, approximately 2.7 million individuals are identified as atrial fibrillation patients, which contribute to 20% of all the reported ischemic stroke cases. Statistics suggest that atrial fibrillation increases the risk of ischemic stroke (the most common variety) approximately 5 -old.
Biswajit Kar, another co- investigator and chief medical division officer at HVI, explained the symptoms of atrial fibrillation in these words:
“Symptoms of atrial fibrillation can include a racing heart and shortness of breath. Over time, it can lead to heart failure.”
Most patients of cardiac rhythmic abnormalities are prescribed blood thinners (dabigatran and warfarin being the most common variety) to minimize the risk of clot formation and resulting ischemic stroke; however, Dr. Richard Smalling explained that anti- coagulant therapy has its own disadvantages: “The biggest drawback of warfarin is that patients need regular blood tests to check levels of the drug, which typically keep changing, causing cardiologists to adjust the dosage to prevent dangerous bleeding.”
Assistant professor in the Complex Arrhythmia Center and co- investigator in the study, Saumya Sharma expressed her views:
“Dabigatran remains at more consistent levels in the body but there is no reversal agent for it, so if a person is in an automobile or other accident, there is a risk for excessive bleeding”
AMPLATZER™ is a primarily designed to seal off the left atrial appendage. It is constructed of nitinol mesh (a self-expanding material), which minimizes the risk of clot migration in to the systemic circulation.