Medtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment.
The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic.
During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used both the Cardioblate irrigated RF system and the CryoFlex surgical ablation system. The surgical team used both Medtronic devices to make a pattern of lesions in the heart muscle in order to help it return to its normal rhythm.
“The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF,” Damiano said in a news release.
“We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease,” said Damiano, who is the national principal investigator of the Terminate AF trial.
The study will involve up to 15 centers in the U.S. and up to 160 patients. Researchers will assess patients at one, three, six and 12 months; the primary efficacy endpoint is for patients to not have AF after the removal of antiarrhythmic drug therapy (three months post-procedure).
“An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation,” said John Mack, VP and general manager of Medtronic’s Cardiac Surgery business.
FDA cleared Cardioblate in 2000 and CryoFlex in 2004.