Study of Cardioblate iRF and CryoFlex Devices for Treating Persistent and Longstanding Persistent Atrial Fibrillation During Heart Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for treating non-paroxysmal atrial fibrillation, including persistent and longstanding persistent forms. This multi-center, single-arm, prospective study involves up to 160 participants undergoing concomitant cardiac surgery. The goal is to support an expansion of product labeling for these devices to include treatment of persistent atrial fibrillation. Participants will receive surgical ablation during their planned open-heart surgery. This includes the use of the Cardioblate iRF and CryoFlex hand held devices, with required procedures such as the Cox Maze IV lesion set and closure or amputation of the left atrial appendage. The study does not include a control group and follows patients for 12 months after the procedure. During the study, participants will be monitored for major adverse events up to 30 days post-procedure or hospital discharge and assessed for freedom from atrial fibrillation, atrial flutter, or atrial tachycardia from 6 to 12 months post-procedure. Additional safety and efficacy measures will be collected, including pacemaker implantation rates, quality of life surveys, and procedural success. Follow-up visits and evaluations will continue for 12 months to monitor outcomes and safety.

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