The FDA has cleared St. Jude Medical to initiate a clinical trial of the company’s Duo irrigated ablation catheter for treatment of atrial fibrillation. The device, which already has the European CE mark, features twelve irrigation ports that should provide better cooling of the electrode during ablation.
The IRASE AF trial is the industry’s first and the largest head-to-head IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomize patients 1:1 between the company’s Duo 12 port open irrigated catheter ablation system and an irrigated catheter ablation system that has been approved by the FDA for the treatment of paroxysmal AF, a type of AF that begins suddenly and ends spontaneously. The trial is expected to take about three years to complete and will take place in both the U.S. and international markets with 324 patients.
When the first line of therapy for the treatment of paroxysmal AF using antiarrhythmic medication is ineffective, RF ablation is currently recommended as a second line of therapy for long-term cardiac arrhythmia control. The IRASE AF pivotal study intends to determine whether or not ablation using the company’s Duo 12 port open irrigated catheter system is safe and effective compared to the other market approved catheter for treatment of symptomatic paroxysmal AF. It will also determine if the ablation catheter can be indicated for the treatment of symptomatic paroxysmal AF.
The trial’s primary efficacy endpoints are targeted pulmonary vein isolation (acute) and freedom from symptomatic AF for 12 months (chronic) following the procedure. The primary safety endpoints are freedom from acute major adverse events within seven days of the procedure and chronic major adverse events within 12 months.