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St Jude Medical, announced it has received an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to begin enrollment in the IRASE AF (IRrigated Ablation System Evaluation for AF) trial.
This is a multicentre, randomised, single-blind study evaluating the safety and efficacy of the company’s Duo 12 port open irrigated catheter ablation system for treatment of Atrial Fibrillation (AF).
AF is the most common cardiac arrhythmia (abnormal heartbeat), affecting an estimated 3.3 million Americans and millions more worldwide.
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 randomise 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 US and international markets with 324 patients.
“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,” said the study’s Principal Investigator Dr Andrea Natale of the Texas Cardiac Research Foundation.
“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 potentially important to improving the safety and efficacy of these procedures as this therapy develops. I am hopeful the procedural data we’re collecting will show what a powerful tool RF ablation can be for the successful management of AF.”
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.
“The IRASE AF trial marks an important milestone for St. Jude Medical because it could result in the company’s first atrial fibrillation indication for a catheter ablation system in the US,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division.
“The trial reflects our ongoing commitment to funding research relevant to the electrophysiology medical community and to the development of innovative technologies and devices to treat atrial fibrillation.”
The company’s Duo 12 port open irrigated steerable ablation catheters are used to help 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.
Atrial fibrillation is a condition in which the upper chambers of the heart (atria) beat rapidly and erratically, affecting the heart’s ability to adequately pump blood to its lower chambers (ventricles) and subsequently to the rest of the body.
The most common cardiac arrhythmia (abnormal heartbeat), AF affects an estimated 3.3 million Americans and millions more worldwide. AF is responsible for 15 to 20 percent of all strokes, is a contributor to heart failure and is a leading cause of hospitalisations.