FDAnews Device Daily Bulletin

Medtronic’s VICTORY AF Ablation Trial Enrolls First Patient

Jan. 8, 2014

Medtronic has enrolled the first patient in its VICTORY AF clinical trial to assess the safety of its investigational Phased Radiofrequency system for patients with persistent or longstanding persistent atrial fibrillation whose symptoms are not controlled through medication.

The study — which will enroll 350 patients at 40 centers across the U.S., Europe and Canada — is intended to answer lingering safety questions following a 2007 to 2010 Phase III study.

In the earlier trial, the majority of patients treated with Medtronic’s Phased RF system experienced 90 percent reduction in atrial fibrillation and had ceased medication after six months. However, an FDA advisory panel argued that the study did not meet its safety endpoint and requested additional data on the system.

“In strong collaboration with the FDA, we designed the VICTORY AF trial to evaluate the safety of Phased RF ablation in patients who suffer from persistent or long-standing persistent AF,” Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division, said Monday. “We expect this trial will demonstrate its safety and benefit for this patient population.”

Medtronic spokeswoman Tracy McNulty said full enrollment could take up to two years, with the trial potentially lasting an additional year. The Phased RF system is already in use in Europe, Asia, Africa, Australia and Canada. — Lena Freund

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