Medtronic (NYSE:MDT) today said it’s launching a huge registry study of its new phased radiofrequency ablation technique for treating atrial fibrillation, the Gold AF trial.
The 1,000-patient, 12-month study aims to evaluate the use of Medtronic’s Gold pulmonary vein ablation catheter in treating AF, using the phased RF technology to deliver "customized" ablation energy to block the errant electrical impulses that cause the condition, Medtronic said. The Gold catheter uses electrodes made of its namesake metal, instead of the platinum used in its predecessor, according to the company.
The Fridley, Minn.-based company said more than 30,000 patients have been treated using phased RF, which is approved for the markets in parts of Europe, Asia, South Africa, Australia and Canada (an investigational device exemption trial, Victory AF, is under way in the U.S.).
"The Gold AF Registry will give us the opportunity to further evaluate and uncover best practices for treating patients with phased radiofrequency technology. We’ll be able to review data – in a very large patient cohort – on the PVAC Gold catheter, which maps, ablates and validates pulmonary vein isolation quickly," co-principal investigator Dr. L.V.A. Boersma, of Holland’s St. Antonius Ziekenhuis Nieuwegei, said in prepared remarks.
The Gold catheter has 9 electrodes that can be fired in unison or as subsets. The gold electrodes deliver 4 times more thermal conductivity than platinum, "offering the potential for more accurate temperature measurement and improved power delivery," Medtronic said.
"AF is a growing health concern that affects millions of people worldwide. With the launch of the Gold AF Registry, we will have access to deeper clinical insights to help us meet the needs of patients now and in the future," AF solutions general manager Reggie Groves said in a statement.
