Medtronic has announced that the first patient has been enrolled in the prospective, non-randomised, controlled VICTORY AF clinical trial of patients with persistent or long-standing persistent atrial fibrillation 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.
“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 atrial fibrillation,” said Reggie Groves, vice president and general manager of the AF Solutions division at Medtronic.
Forty centres throughout the United States, Canada and Europe will participate in VICTORY AF (Evaluation of multielectrode Phased RF technology in persistent atrial fibrillation), which will enrol up to 350 symptomatic patients with persistent or long-standing persistent atrial fibrillation for whom medication has not been effective.
The primary objective of the study is to establish the 30-day procedure-related stroke rate and/or device-related stroke rate as <=1.8%. Secondary objectives include six-month effectiveness, rates of pulmonary vein stenosis, and acute procedural success. The principal investigator is Greg Michaud, assistant professor, Harvard Medical School, and director, Center for the Advanced Management of Atrial Fibrillation at Brigham and Women’s Hospital in Boston, USA. The first patient in this study was recently treated by David DeLurgio of Emory University Hospital Midtown in Atlanta, USA.
In the United States, atrial fibrillation ablation catheters currently are available only for treating paroxysmal atrial fibrillation.
The Medtronic Phased RF system is currently approved for use in areas of Europe, Asia, Africa, Australia, and Canada. The company states that more than 20,000 patients in 26 countries have been treated with this system since January 2009.
The Medtronic Phased RF System is investigational in the United States.
VICTORY AF trial
The VICTORY-AF trial is a follow-up to the TTOP-AF (Tailored treatment of permanent atrial fibrillation) study, which was the first randomised clinical trial to compare the Medtronic Phased RF System to conventional medical management of atrial fibrillation (antiarrhythmic drug therapy and direct-current cardioversion). The TTOP-AF data showed that 55.8% of ablation patients had more than a 90% reduction in atrial fibrillation/atrial flutter burden and were free of antiarrhythmic drug therapy at six months [significantly more than the 26.4% of such patients in the medical management group (p<0.0001)]. An FDA Advisory Panel agreed the system was effective, but since it did not meet the pre-specified safety endpoint, the panel encouraged Medtronic to collect additional clinical data on the Phased RF system, which will be done through VICTORY AF.
Medtronic Phased RF system
The Medtronic Phased RF system consists of a generator and endocardial catheters. The system delivers customised RF energy designed to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain atrial fibrillation. The anatomically designed, multi-electrode catheters are intended to allow physicians to identify and selectively ablate a broad area of heart tissue without the need for single-point catheters or complex mapping and navigation equipment.