AtriCure, Inc. a leading innovator of surgical therapies and treatments for atrial fibrillation (AF), atrial appendage (AAG), as well as postoperative pain management, today announced that the first patient has been treated in the HEAL-IST™ trial (NCT 05280093). The first patient was treated by Drs Mark LaMeir and Carlo de Asmundis at the Brussels University Hospital. HEAL-IST trial will assess the safety and effectiveness of the Isolator ® clampSynergy™ from AtriCure for the treatment of drug-refractory patients with inappropriate sinus tachycardia (IST). Sinus tachycardia usually occurs when the body sends signals to increase the heart rate, such as when a person feels stress or during physical exertion during exercise. When this happens unexpectedly or without an easily identifiable reason, the pathology is called inappropriate sinus tachycardia.
The HEAL-IST trial is a single-arm, prospective, multicenter, 142-patient study conducted at 40 centers across the United States and Europe. The therapy being studied involves a hybrid epicardial and endocardial procedure, in which a cardiac surgeon and an electrophysiologist work together to create lesions on the right side of the heart. The primary efficacy endpoint is disappearance of TSI, which is defined as a mean heart rate of less than 90 beats per minute, or a reduction of at least 15% in mean heart rate, compared to to a preoperative reference. The primary safety endpoint concerns side effects related to the intervention or device.
Symptomatic TSI is a serious arrhythmia, which significantly diminishes the quality of life, mainly in young adults, and more particularly, young women, University of Brussels, and co-principal investigator within the framework of the HEAL-IST trial. “Furthermore, because current pharmacological treatment for arrhythmias has limited long-term effect, and society guidelines do not recommend sinus node ablation or modulation, this landmark ablation study A sinus node-sparing hybrid could set a standard of care for these patients”
– Dr. LaMeir, professor and head of Cardiac Surgery, at the Hospital.
Having cardiac surgeons and electrophysiologists working together is, we believe, a safe and highly effective way to treat complex arrhythmias, The HEAL-IST trial provides an example of AtriCure’s leadership and commitment to improving the lives of patients. The therapy has the potential to significantly expand our target markets.”
– Michael Carrel, president and CEO of AtriCure.
TSI is a common disease that is often underdiagnosed or misdiagnosed, There is currently no approved treatment for this disease. The HEAL-IST trial, based on several years of research within our clinic, offers a chance to demonstrate the success of this procedure. ”
Dr. de Asmundis, professor and director of Cardiac Rhythm Management at the University Hospital of Brussels, and co-investigator principal in the trial.