Atrial Fibrillation Ablation Device Comparison Study

Study Overview
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Brief Summary
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Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. It is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. One of the six devices will be selected randomly by card pulled out at the time of enrollment. It is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. This information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.

Detailed Description
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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.

Official Title
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Randomized Comparison of Ablation Devices Used During Surgery for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Dry bipolar radiofrequency (RF) clamp
* Device: Unipolar microwave antenna
* Device: Unipolar cryothermic probe
* Device: Irrigated unipolar RF antenna
* Device: Irrigated bipolar RF clamp
* Device: Hi-intensity focused ultrasound wand


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dry bipolar radiofrequency (RF) clamp<br>used for ablation during surgical procedure | Device: Dry bipolar radiofrequency (RF) clamp<br>* Specified device used for ablation during standard surgical procedure<br>* Other names: AtriCure;|
| Active Comparator: Unipolar microwave antenna<br>used for ablation during surgical procedure | Device: Unipolar microwave antenna<br>* Specified device used for ablation during standard surgical procedure<br>* Other names: Boston Scientific FLEX 10;|
| Active Comparator: Unipolar cryothermic probe<br>used for ablation during surgical procedure | Device: Unipolar cryothermic probe<br>* Specified device used for ablation during standard surgical procedure<br>* Other names: Cryocath SurgiFrost;|
| Active Comparator: Irrigated unipolar RF antenna<br>used for ablation during surgical procedure | Device: Irrigated unipolar RF antenna<br>* Specified device used for ablation during standard surgical procedure<br>* Other names: ESTECH Cobra Adhere;|
| Active Comparator: Irrigated bipolar RF clamp<br>used for ablation during surgical procedure | Device: Irrigated bipolar RF clamp<br>* Specified device used for ablation during standard surgical procedure<br>* Other names: Meditronic Cardioblate BP;|
| Active Comparator: Hi-intensity focused ultrasound wand<br>used for ablation during surgical procedure | Device: Hi-intensity focused ultrasound wand<br>* Specified device used for ablation during standard surgical procedure<br>* Other names: St. Jude Epicor;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, ablation device comparison, ablation in right atria