Trial of cryoablation catheter vs. drug therapy begins enrollment

Medtronic announced the first patient has been enrolled in a trial to assess the safety and efficacy of pulmonary vein isolation with a cryoballoon in patients with symptomatic paroxysmal atrial fibrillation prior to treatment with antiarrhythmic medications.

The STOP AF First trial is a multicenter randomized controlled trial including up to 210 patients, who will be randomized to cryoballoon ablation (Arctic Front Advance Cryoablation System, Medtronic) or antiarrhythmic drug therapy and followed up for 12 months.

“Clinical research shows that about half of patients with symptomatic AF do not respond to antiarrhythmic drugs, leading to recurrence,” Colleen Fowler, vice president and general manager of AF Solutions at Medtronic, said in a press release. “As AF progresses, it becomes more difficult to treat, and has lower long-term success rates. With the number of AF patients expected to increase exponentially in the coming years, this trial will help ascertain whether earlier treatment with cryoballoon can improve outcomes for a greater number of patients.”

In the U.S., cryoballoon ablation is approved for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF and in Europe, it is approved for the treatment of AF.

Disclosure: Fowler is an employee of Medtronic.