During the surgical ablation procedure, surgeons will use the two ablation devices—deploying both "heat" (Cardioblate Irrigated Radio Frequency ablation) and "cold" (CryoFlex cryoablation) as needed—to make a pattern of lesions in the heart muscle, which are intended to help the heart to return to its normal rhythm. The investigational procedure will be conducted to evaluate the treatment of atrial fibrillation in patients during other surgical heart procedures, such as bypass surgery, heart valve repair or replacement.
"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," said Ralph J. Damiano, M.D., chief of the Division of Cardiothoracic Surgery at Washington University School of Medicine and Barnes Jewish Hospital, and national principal investigator of the Terminate AF trial. "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."
An estimated 2.7—6.1 million people in the U.S. have AF, which contributes to an increased risk of stroke and an annual healthcare cost of $6 billion.1
The study, which will be conducted at up to 15 centers in the U.S., will evaluate the safety and efficacy of the Cardioblate iRF and CryoFlex devices in up to 160 patients with a history of non-paroxysmal AF who are undergoing concomitant cardiac surgery. The primary efficacy endpoint is the absence of AF after the removal of antiarrhythmic drug therapy (three months post-procedure). Patients will be assessed at one, three, six and 12 months.
"The commencement of the TERMINATE AF trial furthers our continued commitment to cardiac surgery," said John Mack, vice president and general manager of the Cardiac Surgery business, which is part of the Cardiac and Vascular Group at Medtronic. "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."
The Cardioblate Irrigated RF (IRF) and CryoFlex Surgical Ablation Systems received 510(k) clearance from FDA in 2000 and 2004, respectively, with a general indication to ablate cardiac tissue during cardiac surgery. Neither device is FDA cleared or approved for the treatment of AF.