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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry bipolar radiofrequency (RF) clamp | Active Comparator | used for ablation during surgical procedure |
|
| Unipolar microwave antenna | Active Comparator | used for ablation during surgical procedure |
|
| Unipolar cryothermic probe | Active Comparator | used for ablation during surgical procedure |
|
| Irrigated unipolar RF antenna | Active Comparator | used for ablation during surgical procedure |
|
| Irrigated bipolar RF clamp | Active Comparator | used for ablation during surgical procedure |
|
| Hi-intensity focused ultrasound wand | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry bipolar radiofrequency (RF) clamp | Device | Specified device used for ablation during standard surgical procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam E Saltman, MD | Director Atrial fibrillation Program, Cardiothoracic Surgeon | Principal Investigator |
| Kamran B Ali, MD | Cardiology Fellow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003250 | Constriction |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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used for ablation during surgical procedure
|
| Unipolar microwave antenna | Device | Specified device used for ablation during standard surgical procedure |
|
|
| Unipolar cryothermic probe | Device | Specified device used for ablation during standard surgical procedure |
|
|
| Irrigated unipolar RF antenna | Device | Specified device used for ablation during standard surgical procedure |
|
|
| Irrigated bipolar RF clamp | Device | Specified device used for ablation during standard surgical procedure |
|
|
| Hi-intensity focused ultrasound wand | Device | Specified device used for ablation during standard surgical procedure |
|
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |