Atrial Fibrillation Ablation Device Comparison Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maimonides Medical Center
• Investigators: Principal Investigator: Adam E Saltman, MD, Director Atrial fibrillation Program, Cardiothoracic Surgeon; Principal Investigator: Kamran B Ali, MD, Cardiology Fellow

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): November 20, 2008
• Study Completion (Anticipated): May 1, 2009

Study Registration Dates

• First Submitted: April 25, 2007
• First Submitted That Met QC Criteria: April 26, 2007
• First Posted (Estimate): April 27, 2007

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Atrial fibrillation; ablation device comparison; ablation in right atria
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 06/11/VA07