US-based Medtronic has enrolled the first patient in the Victory AF clinical trial to assess its Phased RF system, designed to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain atrial fibrillation (AF).
The VICTORY AF (Evaluation of Multielectrode Phased RF Technology in Persistent AF) is a prospective, non-randomised, controlled study that will evaluate the safety of this system, while collecting additional effectiveness data.
Medtronic AF Solutions division vice-president and general manager Reggie Groves said: "We expect this trial will demonstrate its safety and benefit for this patient population."
Around 40 centres throughout the US, Canada and Europe will participate in VICTORY AF, which will enrol up to 350 symptomatic patients with persistent or long-standing persistent AF for whom medication has not been effective.
US-based Medtronic has enrolled the first patient in the VICTORY AF clinical trial to assess its Phased RF system, designed to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain atrial fibrillation (AF).
The primary endpoint is to establish the 30-day procedure-related stroke rate below 1.8%. Secondary objectives include six-month effectiveness, rates of pulmonary vein stenosis, and acute procedural success.
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.
The VICTORY-AF trial is a follow-up to the ‘Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF) study, which was the first randomised trial to compare the Phased RF system with the conventional medical management of AF (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 AF/atrial flutter burden and were free of antiarrhythmic drug therapy at six months, which as significantly more than the 26.4% of such patients in the medical management group (p<0.0001).
In the past, the FDA advisory panel voted that the system was effective, but too risky to approve for patients with persistent or long-standing persistent atrial fibrillation.
The Phased RF system consists of a generator and endocardial catheters. It delivers tailored RF energy intended to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain AF.
According to the company, the device is already approved in areas of Europe, Asia, Africa, Australia, and Canada. It has been used on more than 20,000 patients in 26 countries since January 2009.
In the US, 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.