Medtronic (NYSE:MDT) said today it launched a new study examining the use of its Arctic Front Advance cryoballoon in pulmonary vein isolation procedures for patients with symptomatic paroxysmal atrial fibrillation prior to antiarrhythmic medication treatment.
The Fridley, Minn.-based company said that the 1st patient was enrolled in the Stop AF First trial at The Ohio State University Wexner Medical Center by Dr. Jaret Tyler. The trial is slated to enroll a total of 210 patients at 30 US sites, with Dr. Oussama Wazni of the Cleveland Clinic acting as principal investigator.
The prospective, randomized, controlled clinical trial aims to compare the use of cryoballoon ablation to antiarrhythmic drug therapy over 12 months as a 1st-line treatment for patients with symptomatic paroxysmal AF.
“Clinical research shows that about half of patients with symptomatic AF do not respond to antiarrhythmic drugs, leading to recurrence. 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 the cryoballoon can improve outcomes for a greater number of patients,” af solutions biz GM Colleen Fowler said in a press release.
Currently, Medtronic’s Arctic Front Advance system is approved in the US for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF, and in the EU for treatment of atrial fibrillation.
In March, Medtronic enrolled the 1st patient in a similar clinical study, the Stop Persistent AF trial, which aims to explore the effectiveness and safety of pulmonary vein isolation-only treatments for patients with persistent atrial fibrillation using the Arctic Front Advance cryoablation catheter.