Estech Announces FDA Approval to begin Enrollment in ATTAC-AF IDE Trial for the Treatment of Atrial Fibrillation during Cardiac Surgery
First study of its kind using multiple temperature-controlled radiofrequency devices to assess the safety and effectiveness of surgical ablation in treating non-paroxysmal atrial fibrillation.
The Food and Drug Administration (FDA) has given conditional Investigational Device Exemption (IDE) approval to initiate patient enrollment in the Estech-sponsored ATTAC-AF trial. The IDE trial has been designed to evaluate the treatment of atrial fibrillation (AF) utilizing temperature-controlled radiofrequency (TCRF) ablation in patients undergoing cardiac surgery.
The ATTAC-AF trial will enroll cardiac surgery patients who have a history of non-paroxysmal AF. During the cardiac surgical procedure for treatment of coronary or valve disease, patients will also be treated for their atrial fibrillation disease with Estech’s COBRA® Ablation probes utilizing patented TCRF technology. Patients enrolled in the ATTAC-AF trial will be followed for a minimum of one year to determine the success rate for preventing recurrence of AF and to assess the patient’s quality of life following the ablation procedure.
For patients referred for cardiac surgery, non-paroxysmal atrial fibrillation is exceptionally important because its associated morbidity causes significantly poorer survival rates compared to patients with normal sinus rhythm (NSR). Approximately, 30 to 40% of patients undergoing mitral valve repair have pre-existing non-paroxysmal AF.
Patients in NSR following mitral valve operation have increased one and four year survival rates compared with those in AF. The increased rates of morbidity and mortality associated with patients who remain in AF after surgery demonstrate the need for an effective and reliable treatment for AF.