Atrial Fibrillation Ablation Device Comparison Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Maimonides Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00466973
First received: April 25, 2007
Last updated: April 26, 2007
Last verified: April 2007
  Purpose

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 Intervention 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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Ablation Devices Used During Surgery for the Treatment of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

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

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

Estimated Enrollment: 100
Study Start Date: April 2007
Estimated Study Completion Date: May 2009
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466973

Contacts
Contact: Adam E Saltman, MD 718-283-7290 asaltman@maimonidesmed.org
Contact: Kamran B Ali, MD 718-283-6000 kali@maimonidesmed.org

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Adam E Saltman, MD    718-283-7290    asaltman@maimonidesmed.org   
Contact: Kamran B Ali, MD    718-283-6000    kali@maimonidesmed.org   
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Adam E Saltman, MD Director Atrial fibrillation Program, Cardiothoracic Surgeon
Principal Investigator: Kamran B Ali, MD Cardiology Fellow
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00466973     History of Changes
Other Study ID Numbers: 06/11/VA07
Study First Received: April 25, 2007
Last Updated: April 26, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014