March 19, 2007 — Medtronic Inc. has launched its U.S. pivotal clinical trial for the Cardioblate Surgical Ablation System to treat the cause of permanent atrial fibrillation (AF).
The objective of the CURE-AF (Concomitant Utilization of RadioFrequency Energy for Atrial Fibrillation) Trial is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation System at reestablishing the normal heart rhythm in patients with permanent AF requiring concomitant open heart surgery utilizing the modified Cox Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs or coronary artery bypass grafts (CABG) procedures.
Cardioblate is an irrigated radiofrequency surgical ablation system used to create lesions on the heart muscle to block irregular signals of the heart, potentially reestablishing normal heart rhythm.
The treatment used during the trial procedure is called irrigated radiofrequency surgical ablation. When providing this treatment, surgeons use irrigated radiofrequency energy from the Medtronic Cardioblate Surgical Ablation System to create lesions on the heart muscle. These lesions are created to block the irregular electrical signals of the heart, which may stop the AF.
To facilitate study enrollment, additional study information for healthcare providers and potential patients, is available at www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT00431834).