First Patient Enrolled in Medtronic Clinical Trial Comparing Two Atrial Fibrillation Ablation Devices

Medtronic Inc. has enrolled the first patient in its Fire and Ice clinical trial, a prospective, randomized, multinational head-to-head clinical trial comparing the long-term safety, effectiveness and ease of use of the company’s Arctic Front Cardiac CryoAblation System and the Biosense Webster Carto System Guided Thermocool Catheter.

Results from the trial, expected in 2014, could potentially impact atrial fibrillation treatment guidelines by providing further clinical evidence about the benefits of the Arctic Front system in treating a largely underserved patient population.

“Through this study, we hope to further validate the long-term treatment benefits associated with cryoballoon ablation,” said Karl-Heinz Kuck, M.D., principal investigator and director of cardiology, at Asklepios Klinik St. Georg in Hamburg, Germany. “Given the Arctic Front system’s safety and efficacy profile, combined with its straightforward simplicity, this innovative medical technology has the potential to become the standard of care in treating paroxysmal atrial fibrillation.”

The largest clinical study to date to compare two atrial fibrillation ablation devices, the Fire and Ice trial will enroll up to 572 patients from as many as 20 medical centers throughout Europe. Patients participating in the study must be diagnosed with symptomatic paroxysmal atrial fibrillation and must have failed at least one antiarrhythmic drug.

Participants will be followed for an average of one year after initial ablation. The primary endpoint of the trial is the absence of atrial arrhythmias without antiarrhythmic drug therapy and without persistent procedure-related serious adverse events such as strokes, pulmonary vein stenosis and phrenic nerve injury at six and 12 months following ablation. Key secondary endpoints that will be assessed include total procedure duration, time of fluoroscopy and duration of hospital stay as well as quality of life, sedation and the need for atrial flutter ablation.

Medtronic claims its Arctic Front CryoAblation System has proven short- and long-term benefits, noting the system’s advantages have been documented in numerous studies and in the clinical setting. More than 20,000 procedures using the Arctic Front system have been conducted to date, the company said in a news release.

In the trial that convinced the U.S. Food and Drug Administration to approve the Arctic Front CryoAblation System (known as the Sustained Treatment of Paroxysmal Atrial Fibrillation or Stop AF),69.9 percent of patients treated with the technology were free from atrial fibrillation at one year, compared with 7.3 percent of patients treated with drug therapy only. Patients enrolled in the study showed a significant reduction of symptoms, a decrease in the use of anti-arrhythmic drug therapy and substantial improvements in both physical and mental quality of life factors. The study also demonstrated that treatment with the device is safe, with limited serious procedure-related adverse events (3.1 percent).

“Medtronic is committed to building upon a strong foundation of scientific evidence to help inform physicians’ clinical decisions and help them select technologies that are best suited for their individual patients,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions business. “We look forward to further confirming–via this large-scale, multicenter trial–that our cryoballoon ablation technology offers an alternative to radiofrequency ablation.”

To treat atrial fibrillation, the goal of minimally-invasive catheter ablation therapy is to isolate the pulmonary veins by blocking the conduction of electrical signals that trigger erratic heart rhythms in the upper heart chambers. The Arctic Front cryoballoon system freezes and blocks these erratic triggers, while conventional ablation therapy uses radiofrequency energy with a point-by-point catheter to isolate the triggers by heating. The freezing helps the balloon maintain contact with the heart tissue during the procedure, allowing for greater catheter stability. A leading advancement from currently available ablation tools, cryoablation has been shown to be faster for physicians to use than a point-by-point catheter, and it has been proven more effective than anti-arrhythmic drug therapy in treating patients with paroxysmal atrial fibrillation.

About the Arctic Front Cardiac CryoAblation Catheter System
The Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems. The technologies offered in the system include:

• The Arctic Front Cryoballoon, which inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium;
• The FlexCath Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium;
• The Achieve™ Mapping Catheter, an intra-cardiac electrophysiology recording catheter used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation;
• The Freezor MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to provide additional ablations, as needed; and
• The CryoConsole, which houses the coolant, electrical and mechanical components that run the catheters during a cryoablation procedure.