AtriCure receives FDA approval to start DEEP IDE study

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The DEEP study will investigate a minimally invasive approach performed by cardiac surgeons and electrophysiologists to treat patients with persistent or long-standing persistent atrial fibrillation who have failed antiarrhythmic drug therapy.

AtriCure has announced it has received approval for an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to begin enrolment in the DEEP (Dual epicardial and endocardial procedure) clinical trial. The DEEP trial is a prospective, multicentre, single arm, pivotal study to evaluate patients with persistent or long-standing persistent atrial fibrillation. This is the first pivotal study of its kind in the United States.

 

The study is designed to evaluate the safety and efficacy of the DEEP approach in treating non-paroxysmal atrial fibrillation. The DEEP approach utilises the skills of both the cardiac surgeon and electrophysiologist to treat more severe cases of atrial fibrillation.

In the DEEP study, the cardiac surgeon and electrophysiologist work as a team to perform a minimally invasive epicardial ablation and endocardial catheter-based ablation. The primary effectiveness endpoint is freedom from atrial fibrillation and freedom of Class I or III antiarrhythmic drug therapy. AtriCure has FDA approval to enrol 220 patients at up to 25 sites in the USA and internationally.


Atrial fibrillation patients who have failed antiarrhythmic drug therapy and received up to two failed catheter ablations are candidates for the DEEP study, which is performed in two phases. In the first phase, the surgeon will make small incisions to perform endoscopic epicardial ablation using the AtriCure Bipolar System, and occlude the left atrial appendage with the AtriClip LAA Exclusion System. Then about three months later, the patient will undergo an endocardial mapping and catheter ablation procedure performed by the electrophysiologist.


“AtriCure is embarking on this landmark trial which will bring electrophysiologists and cardiac surgeons together as a team in an effort to establish a new standard of care for patients presenting with persistent or long-standing persistent atrial fibrillation, a significant risk factor for stroke,” says James L Cox, Emeritus Evarts A Graham Professor of Surgery at Washington University, USA. “AtriCure is fortunate to have such a distinguished group of physicians to provide leadership for this important trial.”


The principal investigators for DEEP are Kenneth Ellenbogen, chairman of the Division of Cardiology at Virginia Commonwealth University (VCU) Pauley Heart Center; Paul Wang, director, Stanford Arrhythmia Service, professor of Medicine and Bioengineering, by courtesy, Stanford University School of Medicine; Vigneshwar Kasirajan, chairman, department of Surgery and Division of Cardiothoracic Surgery and professor, Department of Surgery at VCU Pauley Heart Center; and Ali Khoynezhad, professor of Cardiovascular Surgery at Cedars-Sinai Heart Institute.


“We look forward to pioneering the multi-specialty approach where electrophysiologists will work more closely with cardiac surgeons in this dual surgical approach,” says Ellenbogen.


“The DEEP procedure combines the expertise of both the electrophysiologist and cardiac surgeon and seeks to set a new standard of care for atrial fibrillation ablation therapy,” says Kasirajan.


“The DEEP procedure is an integrated and minimally-invasive approach to resistant atrial fibrillation combining the strengths of multi-specialty ablation techniques. I am excited about the DEEP trial and evaluating patients with non-paroxysmal atrial fibrillation for whom the outcome of traditional endocardial ablation has been challenging,” says Khoynezhad.


“We are pleased to be moving into this next phase of a pivotal trial for DEEP,” says Mike Carrel, chief executive officer of AtriCure. “Our goal is to start the Institutional Review Board process with many of the leading institutions right away. We intend to have our first subject enrolled in early 2015, with completion of enrolment targeted for mid-2017.”

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