CURE-AF Trial Information

What is the CURE-AF trial?

The purpose of the CURE-AF trial is to determine the safety and effectiveness of the Medtronic^® Cardioblate^® Surgical Ablation System in the treatment of permanent AF.

Who can take part in CURE-AF?

If you are 18 years of age or older, are scheduled to have heart surgery [mitral valve repair or replacement, coronary artery bypass, aortic valve repair or replacement, tricuspid valve repair or replacement, atrial septal defect (ASD) repair or patent foramen ovale (PFO) closure], and have a documented history of permanent AF, you may be considered for this trial. Your physician will look at your medical history to see if you meet all the requirements for participating in this study.

Why should I consider participating in the trial?

The CURE-AF trial is part of an effort to find better treatment options for the debilitating condition of AF. By participating in the trial, you will be joining a team of physicians, researchers and patients who will help to further the understanding of the treatment of AF.

What is the treatment that is being tested?

The treatment 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 (lines of scars) on the heart muscle. These lesions are created to block the irregular electrical signals of your heart, which may stop the AF.

What are the potential benefits of irrigated radiofrequency surgical ablation?

Irrigated radiofrequency surgical ablation treatment may free patients from AF and reduce or eliminate the need for medications and their associated side effects or complications. Studies such as this one are conducted to determine the risks and benefits of treatments, so no benefits can be guaranteed.

What are the potential benefits of the CURE-AF Clinical Study?

You might benefit from having this procedure through the increased follow-up required by the study. The Cardioblate Surgical Ablation System^® may help to restore a regular heart rate and rhythm. This may help bring back normal atrial functions and reduce or get rid of your AF symptoms.

Increased follow-up visits will monitor you more frequently and may detect if your heart goes out of rhythm sooner than if you were not being followed by this study.

However, we cannot guarantee that you will experience medical benefits from participating in this study. Others may benefit in the future from the information we obtain while you are in this study.

What are the potential risks of the CURE-AF Clinical Study?

There are some possible risks and/or discomforts associated with making lesions to treat AF during open-heart surgery and participation in this study.

There are risks that could also occur as a result of the open-heart surgery with or without the Medtronic Cardioblate Surgical Ablation System^®. Your doctor will discuss the risks associated with your open-heart surgery and explain the potential treatments for those risks.

If I participate in the CURE-AF trial, will I receive the irrigated radiofrequency surgical ablation treatment?

If you become a participant in this research, you will undergo heart surgery for your valve, coronary bypass, ASD or PFO as planned. You will also receive the Maze procedure using irrigated radiofrequency ablation for AF. As part of the research, you will visit your doctor at regular intervals.