St Jude Medical has received an Investigational Device Exemption (IDE) from the FDA to begin enrollment in the IRrigated Ablation System Evaluation for Atrial Fibrillation (IRASE AF ) trial. The trial is a multicenter, randomised, single-blind study evaluating the safety and efficacy of the Duo 12 port open irrigated catheter ablation system for treatment of AF.
The company said that the Duo 12 port open irrigated steerable ablation catheters are used to treat cardiac arrhythmias and have European CE Mark approval. The 12 irrigation ports on the proximal area of the tip electrode are designed to ensure more uniform cooling of the ablation tip.
The IRASE AF trial is the IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomise patients 1:1 between the 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 company said that 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.
Andrea Natale, the principal investigator of the study at the Texas Cardiac Research Foundation, said: “With the IRASE AF trial, we hope to learn more about how safe and effective St Jude Medical’s Duo 12 port tip irrigated ablation catheters are as part of an ablation strategy to treat atrial fibrillation. I believe catheter ablation is an important treatment option for AF patients.
“Technology innovation and enhancements to the catheters we use, such as the Duo tip, are important to improve the safety and efficacy of these procedures as this therapy develops. I am hopeful the procedural data we’re collecting will show a powerful tool and RF ablation can be the successful management of AF.”