AtriCure has announced that the first patient has been treated in the HEAL-IST trial, evaluating the safety and effectiveness of AtriCure’s Isolator Synergy Clamp for the treatment of drug-refractory patients diagnosed with inappropriate sinus tachycardia (IST). The first patient was treated by Mark LaMeir and Carlo de Asmundis at University Hospital Brussels, Brussels, Belgium.
Sinus tachycardia normally occurs when the body sends out signals to make the heart beat faster, such as when some people experience stress or physical exertion during exercise. When it happens unexpectedly or for no easily identifiable reason, the condition is called inappropriate sinus tachycardia.
The HEAL-IST trial is a prospective, multicentre, single-arm study of 142 patients at up to 40 centres in the USA and Europe. The therapy being studied involves a hybrid epicardial and endocardial procedure, during which a cardiac surgeon and an electrophysiologist work together to create lesions on the right side of the heart.
The primary effectiveness endpoint is freedom from IST, defined as having a mean heart rate of less than 90 beats per minute, or at least a 15% reduction in mean heart rate compared to a pre-operative baseline. The primary safety endpoint is procedure or device related adverse events through 30 days after the surgery is completed.
“Symptomatic IST is a serious arrhythmia that dramatically decreases the quality of life in predominantly younger adults, and more specifically, young women,” said LaMeir, co-principal investigator in the HEAL-IST trial. “Further, since current antiarrhythmic drug treatment has limited long-term effect, and societal guidelines do not advise sinus node ablation or modulation, this landmark study of sinus node sparing hybrid ablation has the potential to establish a standard of care for these patients.”
“We believe that cardiac surgeons and electrophysiologists working together is a safe and highly effective way to treat complex arrhythmias,” said Michael Carrel, president and chief eexecutive Officer of AtriCure. “The HEAL-IST trial is an example of AtriCure’s commitment to, and leadership in improving the lives of patients. The therapy has the potential to significantly expand our addressable markets.”
“IST is a common disease that is often under or misdiagnosed,” said Dr. de Asmundis, Professor and Director of Heart Rhythm Management at University Hospital Brussels, and co-principal investigator in the trial. “There are currently no approved treatments for this disease. The HEAL-IST trial, which is based on years of research from our clinic, has a chance to prove how successful this procedure can be.”