Atrial Fibrillation Ablation Device Comparison Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466973
Recruitment Status : Unknown
Verified April 2007 by Maimonides Medical Center.
Recruitment status was:  Recruiting
First Posted : April 27, 2007
Last Update Posted : April 27, 2007
Information provided by:
Maimonides Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: AtriCure dry bipolar radiofrequency (RF) clamp Device: Boston Scientific FLEX 10 unipolar microwave antenna Device: Cryocath SurgiFrost unipolar cryothermic probe Device: ESTECH Cobra Adhere irrigated unipolar RF antenna Device: Medtronic Cardioblate BP irrigated bipolar RF clamp Device: St. Jude Epicor hi-intensity focused ultrasound wand Early Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Ablation Devices Used During Surgery for the Treatment of Atrial Fibrillation
Study Start Date : April 2007
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Freedom from Atrial fibrillation
  2. Rhythm at 12 months
  3. MACE at 1 and 3 months

Secondary Outcome Measures :
  1. Functional and qualitative improvement in heart failure, ejection fraction, left atrial size, exercise tolerance
  2. Rhythm at 3, 6 and 9 months
  3. All other adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00466973

Contact: Adam E Saltman, MD 718-283-7290
Contact: Kamran B Ali, MD 718-283-6000

United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Adam E Saltman, MD    718-283-7290   
Contact: Kamran B Ali, MD    718-283-6000   
Sponsors and Collaborators
Maimonides Medical Center
Principal Investigator: Adam E Saltman, MD Director Atrial fibrillation Program, Cardiothoracic Surgeon
Principal Investigator: Kamran B Ali, MD Cardiology Fellow Identifier: NCT00466973     History of Changes
Other Study ID Numbers: 06/11/VA07
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Maimonides Medical Center:
Atrial fibrillation
ablation device comparison
ablation in right atria

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes