Mayo Clinic received US$48 million in grants from the National Heart, Lung, and Blood Institute (NHLBI), a component of the American National Institutes of Health (NIH), and from industry to study the treatment of atrial fibrillation in 3,000 patients and 140 centres around the world. Mayo Clinic is leading the study.
The CABANA (Catheter ablation versus anti-arrhythmic drug therapy for atrial fibrillation) trial is designed to determine whether catheter ablation is more effective than drug therapy for the treatment of atrial fibrillation, says Douglas Packer, the trial’s principal investigator and a cardiologist at Mayo Clinic. The study, which will take six years from beginning to releasing results, is a collaborative effort among Packer and Richard Robb, at Mayo Clinic, Kerry Lee, and Daniel Mark, at Duke Clinical Research Institute in Durham, and the NHLBI.
Funding for the trial consists of US$18 million from NHLBI/NIH, US$20 million from St Jude Medical and US$10 million from Biosense Webster.
The trial will determine whether left atrial catheter ablation to eliminate atrial fibrillation is better than current state-of-the-art drug therapy, Packer says. The trial also will examine atrial fibrillation recurrence, stroke risk, quality of life and cost-effectiveness.
The study will randomise patients over three years, with half undergoing catheter ablation and half receiving rate control or rhythm control drug therapy. Further information about this trial (NCT00911508) can be found at www.clinicaltrials.gov.
“While prior trials have investigated the effectiveness of ablation in treating AF, their value in guiding the treatment of patients is limited by the small size of the studies, relatively short follow-up periods, and the exclusion of older patients with more long-standing AF as well as underlying disease. CABANA will include these patients and follow them for a much longer time period to more clearly define optimal therapy for AF,” Packer says. “We believe that CABANA will be a landmark trial that will guide therapy in the atrial fibrillation arena for years to come.”
Before these grants were awarded, Mayo Clinic led a 10-centre, 60-patient pilot study. Those results will be announced later this summer.
The CABANA trial will be conducted as a collaboration between the Heart Rhythm Service and Biomedical Imaging Resource Center at Mayo Clinic, Duke Clinical Research Institute, and CABANA investigators from the 140 centres around the world.
Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. More than 3,300 physicians, scientists and researchers and 46,000 allied health staff work at Mayo Clinic, which has sites in Rochester, Jacksonville, and Scottsdale/Phoenix. Collectively, the three locations treat more than half a million people each year.