Atrial Fibrillation Ablation Device Comparison Study

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.

Conditions

• Atrial Fibrillation

Interventions

DEVICE

Dry bipolar radiofrequency (RF) clamp

Specified device used for ablation during standard surgical procedure

DEVICE

Unipolar microwave antenna

Specified device used for ablation during standard surgical procedure

DEVICE

Unipolar cryothermic probe

Specified device used for ablation during standard surgical procedure

DEVICE

Irrigated unipolar RF antenna

Specified device used for ablation during standard surgical procedure

DEVICE

Irrigated bipolar RF clamp

Specified device used for ablation during standard surgical procedure

DEVICE

Hi-intensity focused ultrasound wand

Specified device used for ablation during standard surgical procedure

Sponsors & Collaborators

• Maimonides Medical Center

  lead OTHER

Principal Investigators

• Adam E Saltman, MD · Director Atrial fibrillation Program, Cardiothoracic Surgeon

• Kamran B Ali, MD · Cardiology Fellow

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2008-11-20

Completion

2009-05-31

Countries

• United States

Study Locations