Medtronic Announces Initiation of U.S. Pivotal Trial to Evaluate the Cardioblate Surgical Ablation System to Treat Permanent Atrial Fibrillation

Medtronic, Inc. (NYSE: MDT), announced today the start of the U.S. pivotal clinical trial for the Cardioblate® Surgical Ablation System to treat the cause of permanent atrial fibrillation (AF). The Medtronic Cardioblate® Surgical Ablation System is an irrigated radiofrequency surgical ablation system used to create lesions on the heart muscle to block irregular signals of the heart, potentially reestablishing normal heart rhythm. AF is a condition that affects approximately 5.5 million people worldwide, with approximately one-third of these patients categorized as suffering from permanent or chronic AF. People with AF are at increased risk of stroke, have a shorter life expectancy, and may develop symptoms such as shortness of breath.

The purpose of the CURE-AF (Concomitant Utilization of RadioFrequency Energy for Atrial Fibrillation) Trial is to evaluate the safety and effectiveness of the Medtronic Cardioblate Surgical Ablation System at reestablishing the normal heart rhythm in patients with permanent AF requiring concomitant open heart surgery utilizing the modified Cox Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs or coronary artery bypass grafts (CABG) procedures.

The treatment used during the trial procedure is called irrigated radiofrequency surgical ablation. When providing this treatment, surgeons use irrigated radiofrequency energy from the Medtronic Cardioblate Surgical Ablation System to create lesions on the heart muscle. These lesions are created to block the irregular electrical signals of the heart, which may stop the AF. To facilitate study enrollment, additional study information for healthcare providers and potential patients, is available at www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT00431834).

“Patients who have permanent AF are at significant risk for stroke and death when compared to patients in normal sinus rhythm. In addition, these patients can experience uncomfortable symptoms from their AF including heart palpitations, dizziness, fatigue and shortness of breath. AF also has been shown to lead to heart failure in some patients,” said co-principal trial investigator Dr. Ralph Damiano, Barnes Jewish Hospital. “Our ability to safely and effectively surgically ablate areas of heart muscle to block AF will be an important step forward in improving both quality of life and survival for these patients.”

The prospective, non-randomized, clinical trial will enroll 75 patients at 10 U.S. medical centers. The primary endpoints of the trial are to evaluate the freedom from permanent atrial fibrillation in patients off antiarrhythmic drugs at six months, with the composite major adverse event rate at one month.
The results of the trial will be submitted to the FDA to obtain an indication for the Medtronic Cardioblate Surgical Ablation System in the treatment of permanent atrial fibrillation in patients requiring concomitant open heart surgery.

“Due to the complexity and length of traditional surgical procedures for permanent AF, such as the Cox Maze III procedure, it was important for Medtronic to study potentially easier and safer techniques for the Cardiac Surgeon to offer to their patients suffering from permanent AF,” said Dr. John Liddicoat, vice president of Structural Heart Disease in the Cardiac Surgery business at Medtronic. “We are pleased to begin enrollment in the CURE-AF trial and hope to begin providing relief to so many patients suffering from the debilitating effects of permanent AF.”

According to the American Heart Association, atrial fibrillation is estimated to affect more than 5.5 million people worldwide. Prevalence of the disease increases with age, doubling in each decade after age 50. During atrial fibrillation, the heart's two small upper chambers (the atria) quiver instead of beating effectively. As a result blood isn't pumped completely out of the atria, so it may pool and clot. If a piece of a blood clots in the atria and leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation.