According to the American Heart Association, more than two million Americans suffer from atrial fibrillation, a cardiovascular disorder that causes an irregular heart rhythm. Treatment for atrial fibrillation can range from medications to surgery, depending on the severity of the condition. Eisenhower Medical Center has joined an elite group of only ten internationally renowned hospitals, including Cleveland Clinic and Mayo Clinic, in a pivotal clinical trial that is testing the next innovative treatment and possible cure for atrial fibrillation.
The clinical trial, entitled Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation (CURE-AF), evaluates the safety and effectiveness of the Medtronic® Cardioblate® Surgical Ablation System at restoring normal heart rhythm in patients with permanent atrial fibrillation or persistent atrial fibrillation who also require open heart surgery.
The irrigated radiofrequency surgical ablation treatment used during the trial procedure uses irrigated radiofrequency energy to create lesions on the heart muscle utilizing the modified Cox Maze III procedure. These lesions are created to essentially block the irregular electrical signals of the heart, potentially stopping atrial fibrillation.
The maze procedure is the gold standard for correcting atrial fibrillation. Most patients who undergo this procedure have not responded to drug treatment to control their arrhythmias. Performed in conjunction with a coronary artery bypass graft or heart valve repair or replacement, the surgeon creates a path or “maze” through which electrical impulses can be directed. The scar tissue that forms from the lesions keeps the electrical impulses moving in a specified pattern. The procedure only adds approximately 15 minutes to the open-heart surgery and offers few complications, little blood loss, as well as shortened hospitalization and recovery time.
Eisenhower Cardiovascular Surgeons S. N. Mitruka, MD and Joseph W. Wilson, MD are the principal investigators of the CURE-AF trial at Eisenhower Medical Center. “Patients who have permanent atrial fibrillation are at significant risk for stroke. These patients can experience uncomfortable symptoms from atrial fibrillation, including heart palpitations, fatigue, dizziness and shortness of breath,” says Dr. Mitruka. “The treatment used in the CURE-AF trial to surgically ablate areas of the heart muscle to block atrial fibrillation safely and effectively will be an important step forward in improving the quality of life for our patients.”
Patients requiring valve replacements or repairs, atrial septal defect repairs or coronary artery bypass graft procedures may qualify for the clinical trial. To learn more about the CURE-AF clinical trial at Eisenhower, call 760-568-4330.