Study ID: Terminate AF
Medtronic Terminate AF study
This purpose of this study is to demonstrate the safety and effectiveness of certain handheld devices for the treatment of persistent atrial fibrillation. The handheld devices are the Cardioblate iRF and the Cardioblate Cryoflex, which have been commercially available since 2000 and approved for cardiac tissue ablation. This study is seeking an expanded approval specifically for persistent and longstanding persistent AF. To be eligible, patients will have cardiac surgery, such as coronary artery bypass, valve repair or valve replacement. Then if eligible, they will have the ablation for Afib. Ablation permanently blocks abnormal electrical signals.
Participants will be assessed after the procedure and followed for up to 12 months.
History of non-paroxysmal atrial fibrillation (persistent or longstanding persistent). Concomitant indication for nonemergent open-heart surgery, such as coronary artery bypass grafting as well as valve repair or replacement.
Intervention/treatment: Surgical ablation using Cardioblate and Cryoflex handheld devices. In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage. The Cox Maze IV lesion set is required to be performed.
- Must have history of atrial fibrillation
- Must require nonemergent open-heart surgery, such as coronary artery bypass, or valve repair or replacement
- Must be able to take warfarin or newer blood thinners
Additional criteria may apply.