Atrial Fibrillation Ablation Device Comparison Study

Surgery has been used as a treatment for atrial fibrillation (AF) for more than 20 years. Although highly successful, it has not been widely adopted because operations designed to cure AF require extensive cutting and suturing of the heart, inflicting a significant risk on the patient. Newer technologies now permit the surgeon to create similar scars on the heart as cutting, but much more quickly and safely than before.

Over the last ten years at least six different devices have been developed, each of which can scar the heart: Microwave, radiofrequency, ultrasound, laser and cold are some of them. Although there are many papers in the literature studying these devices, each seems to cure about 80% of patients with very low risk of morbidity and/or mortality. This leaves the surgeon with almost no basis upon which to base his or her selection of a device: Which is the best? Which should be used? Therefore, a comparison study is like this is desperately needed.

At the time of the surgery, surgeon who perform the AF treatment, he or she will select one of the six devices mentioned above at randomly assigned earlier, at the time of the enrollment. The device will be used to make scars on your heart exactly as described in the manufacturer's instructions and according to the surgeon's experience. The operation will then be completed per routine. In other words, the only part of the procedure that will be done differently from any other is that the actual device chosen to perform the ablation will vary from one study subject to another.

Patients will be followed up upto one year with EKGs, Holter monitors, MRI's, 6 minute walk tests, echocardiograms, blood tests like bNP and quality of life questionnaires.

• Dry bipolar radiofrequency (RF) clamp (Device), also known as AtriCure: Specified device used for ablation during standard surgical procedure
• Unipolar microwave antenna (Device), also known as Boston Scientific FLEX 10: Specified device used for ablation during standard surgical procedure
• Unipolar cryothermic probe (Device), also known as Cryocath SurgiFrost: Specified device used for ablation during standard surgical procedure
• Irrigated unipolar RF antenna (Device), also known as ESTECH Cobra Adhere: Specified device used for ablation during standard surgical procedure
• Irrigated bipolar RF clamp (Device), also known as Meditronic Cardioblate BP: Specified device used for ablation during standard surgical procedure
• Hi-intensity focused ultrasound wand (Device), also known as St. Jude Epicor: Specified device used for ablation during standard surgical procedure

Primary outcomes

• Freedom from Atrial fibrillation [3 months after surgery]: No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, Brain Natriuretic Peptide (BNP) levels
• Rhythm at 12 months [12 months after surgery]: No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, BNP levels
• Major Adverse Cardiovascular Events (MACEs) at 1 and 3 months [1 and 3 months post-surgical procedure]: Recording any major adverse cardiovascular events reported

Secondary outcomes

• Functional and qualitative improvement in heart failure, ejection fraction, left atrial size, exercise tolerance [6 and 12 months post-surgical procedure]: Quality of life questionnaire
• Rhythm at 3, 6 and 9 months [3, 6 and 9 months post-surgical procedure]: No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, BNP levels
• All other adverse events [From surgical procedure through 12 months follow-up]: Any adverse events noted throughout period

Sex: All, ages: 19 Years to 75 Years

Inclusion Criteria:

* All patients undergoing concomitant cardiac surgery who also have AF.

Exclusion Criteria:

* Patients undergoing re-do or emergency procedures
* Females of child-bearing age who are pregnant
* Age less than 19 and more than 75 years old

• Adam E Saltman, MD, Principal investigator, Director Atrial fibrillation Program, Cardiothoracic Surgeon
• Kamran B Ali, MD, Principal investigator, Cardiology Fellow