Medtronic Expands CURE-AF Clinical Trial To Aid FDA Approval of Irrigated Ablation With RF
January 29, 2009 - Medtronic Inc. today reported the expansion of its CURE-AF (Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation) U.S. clinical program with a post-market study in Europe and Canada.
Originally only in the United States, CURE-AF is being conducted to secure FDA Clearance of Cardioblate for the investigational treatment of atrial fibrillation (AF). The program will now collect post-market data internationally on the efficacy of irrigated cardiac ablation with radiofrequency (RF) energy in AF patients.
AF is the most common cardiac arrhythmia, and is associated with a five-fold increase in a patient’s likelihood of suffering a stroke, which can frequently be debilitating and fatal, accounting for one in every 16 American deaths, the company said.
The CURE-AF study is investigating the treatment of AF during an open-heart operation such as valve repair or coronary artery bypass graft (CABG). During the procedure, a surgeon uses Medtronic’s Cardioblate System to create a pattern of transmural lesions, i.e., lesions which span the full thickness of heart tissue. The pattern of lesions is modeled after the highly efficacious Cox Maze procedure. Transmurality of the lesions is required for conduction block, which in turn is essential for the prevention of abnormal conduction associated with AF, and for the potential to restore normal heart rhythm.
The Cardioblate surgical ablation system reportedly achieves consistent transmural lesions with irrigated RF energy. It is currently indicated for cardiac tissue ablation, and has been used in more than 90,000 procedures worldwide.
“We are delighted to be able to join this research effort,” said Dr. Alexander Wahba, professor of cardio-thoracic surgery at St. Olavs University Hospital, Trondheim, Norway. “If successful in its objectives, CURE-AF will allow the introduction of a new treatment option for many patients who otherwise might endure an untreated arrhythmia and the considerable associated risks.”
For mo information: www.medtronic.com