Medtronic, Inc. has announced the first patient has been enrolled in the VICTORY AF clinical trial, a prospective, non-randomized, controlled study of patients with persistent or long-standing persistent atrial fibrillation (AF) undergoing an ablation procedure with Medtronic's Phased Radiofrequency (RF) system. The study will evaluate the safety of this system, while collecting additional effectiveness data. The Medtronic Phased RF System is investigational in the United States.
"In strong collaboration with the FDA, we designed the VICTORY AF trial to evaluate the safety of Phased RF ablation in patients who suffer with persistent or long-standing persistent AF," said Reggie Groves, vice president and general manager of the AF Solutions division at Medtronic. "We expect this trial will demonstrate its safety and benefit for this patient population."
Forty centers throughout the United States, Canada and Europe will participate in VICTORY AF (Evaluation of Multielectrode Phased RF Technology in Persistent AF), which will enroll up to 350 symptomatic patients with persistent or long-standing persistent AF for whom medication has not been effective. The primary study objective is to establish the 30-day procedure-related stroke rate and/or device-related stroke rate as <=1.8 percent. Secondary objectives include six-month effectiveness, rates of pulmonary vein stenosis, and acute procedural success. The principal investigator is Greg Michaud, M.D., assistant professor, Harvard Medical School, and director, Center for the Advanced Management of Atrial Fibrillation at Brigham and Women's Hospital in Boston. The first patient in this study was recently treated by Dr. David DeLurgio of Emory University Hospital Midtown in Atlanta.
Persistent AF is defined as sustained AF lasting more than seven days but less than one year, or lasting fewer than seven days but requiring cardioversion through medication or electrical current. Long-standing persistent AF is defined as continuous AF lasting more than one year but fewer than four years.
In the United States, AF ablation catheters currently are available only for treating the mildest form of AF (paroxysmal AF) in which the heart's upper chambers beat rapidly and irregularly during episodes lasting from a few minutes to a few days. AF can progress into a persistent or long-standing persistent state, where patients are often drug refractory, meaning that there is no effective medication to treat the condition. Patients with persistent and long-standing persistent AF can have debilitating symptoms and are at elevated risk for stroke, hospitalizations and reduced quality of life.
The Medtronic Phased RF System is currently approved for use in areas of Europe, Asia, Africa, Australia, and Canada. More than 20,000 patients in 26 countries have been treated with this system since January 2009.