Cardiac medical device maker AtriCure Inc. (NASDAQ:ATRC) has enrolled the first patient in a clinical trial designed to test a hybrid procedure on patients with persistent atrial fibrillation, a condition marked by irregular heart rhythm.
The procedure being evaluated in the study combines AtriCure’s minimally invasive surgical ablation devices with a catheter-based ablation system from BioSense Webster, a Johnson & Johnson company, according to a statement from AtriCure.
The hybrid procedure also incorporates endovascular mapping, which refers to using imaging technology to “see” the effects of ablation procedures in real-time. The idea is to combine the skills of cardiac surgeons and electrophysiologists to treat atrial fibrillation patients.
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AtriCure earlier this year received regulatory approval to move ahead with the trial, which it calls DEEP AF.
The first patient was treated at Sentara Norfolk General Hospital in Norfolk, Virginia. AtriCure plans to enroll 30 patients in the trial at six medical centers across the United States. The company hopes to complete enrollment by summer 2011, CFO Julie Piton said.
The Food and Drug Administration hasn’t approved any products for the treatment of patients suffering from persistent atrial fibrillation, a condition that’s estimated to describe 60 percent of the 5.5 million people affected by atrial fibrillation, according to the American Heart Association.
The FDA also has not approved cardiac ablation as a treatment for atrial fibrillation. AtriCure has been at the forefront of clinical trials to convince the federal regulator to give its approval, which would be a huge boost for the company’s business.
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Ablation refers to creating precise scars on the heart. The scars, which can be created by using radiofrequency energy, or extreme cold or heat, are intended to interrupt the path of abnormal electrical impulses that cause atrial fibrillation.
AtriCure is currently conducting another clinical trial called “ABLATE” for atrial fibrillation patients. In that trial, patients are treated with an open-heart procedure. In the DEEP AF trial, patients are treated with a minimally invasive procedure, Piton said.
In June, AtriCure got FDA approval to sell its AtriClip device, which is a clip used during heart surgery to exclude the left atrial appendage. This exclusion helps protect atrial fibrillation patients from strokes. The device is not being tested in the ABLATE or DEEP AF trials.
