The study is evaluating two surgical ablation devices, the Cardioblate Irrigated RF (IRF) System and the CryoFlex Surgical Ablation System, for the treatment of non-paroxysmal (persistent or longstanding persistent) AF in patients undergoing open-heart surgical procedures.
After receiving approval from the US Food and Drug Administration (FDA), the first patient was treated in the study at Washington University School of Medicine in St. Louis. In the US, the use for treatment of AF is investigational use only.
It is estimated that the nearly 2.7 – 6.1 million people in the US suffer from AF and it contributes to an increased risk of stroke and an annual healthcare cost of $6bn.
Medtronic stated that 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. This makes 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 in other surgical heart procedures including bypass surgery, heart valve repair or replacement.
The study will be conducted at up to 15 centers in the US and 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 company claims that 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.
Medtronic Cardiac and Vascular Group Cardiac Surgery business vice president and general manager John Mack said: “The commencement of the Terminate AF trial furthers our continued commitment to cardiac surgery.
“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.”
