First US clinical study to assess ablation for monomorphic ventricular ablation initiated

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Abbott has announced the start of LESS-VT—the first US clinical trial to evaluate the safety and effectiveness of ablation treatment for patients with monomorphic ventricular tachycardia. The LESS-VT study, which is currently enrolling patients, will evaluate the safety and effectiveness of ablation delivered by the FlexAbility ablation catheter (Abbott), Sensor Enabled (SE), for the treatment of monomorphic ventricular tachycardia for people who are unresponsive to drug therapy.

Over the next two years, a press release reports, Abbott expects to enrol more than 600 patients at 35 sites in the USA and Europe. The results will help expand the health care community’s understanding of using radiofrequency ablation therapy as a frontline treatment for patients suffering from ventricular tachycardia. The study is also designed to support Abbott’s submission for FDA approval of an indication expansion for the company’s ablation therapy.

Paolo Della Bella (San Raffaele Hospital, Milan, Italy), an electrophysiologist on the LESS-VT trial steering committee, comments: “For some patients with sustained monomorphic ventricular tachycardia, drug therapy is an ineffective treatment option,” said “We want to build a body of clinical evidence that establishes ablation as a therapy solution for people with ischemic and non-ischaemic monomorphic ventricular tachycardia.”

In addition to the FlexAbility SE ablation catheter, Abbott also recently introduced the Advisor HD Grid mapping catheter to support treatment of conditions such as monomorphic ventricular tachycardia. The Advisor HD Grid catheter is designed to capture information—such as the direction of cardiac signals—often missed with traditional mapping catheters. Advisor HD Grid offers physicians a unique grid configuration that captures this critical information and enables the creation of high-density maps of cardiac tissue to support treatment for patients.

Srijoy Mahapatra, medical director of Abbott’s electrophysiology business, comments: “Data suggest treating people with arrhythmias, including sustained monomorphic ventricular tachycardia, reduces the risk of developing other complications and hospitalizations. The goal of the LESS-VT study is to provide physicians with relevant data to help them determine the most effective treatment option for their patients with monomorphic ventricular tachycardia. With recent advances in Abbott’s unique ablation tools and cardiac mapping technology, we aim to uncover treatment strategies to benefit patients so they can return to living healthy, full lives.”

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