AtriCure Announces the First Patient Treated in the HEAL-IST Clinical Trial
June 07 2022 - 8:00AM
Business Wire
Trial will evaluate the safety and
effectiveness of AtriCure’s Isolator® Synergy™ Clamp in conjunction
with endocardial catheter ablation for the treatment of
Inappropriate Sinus Tachycardia
AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical
treatments and therapies for atrial fibrillation (Afib), left
atrial appendage (LAA) management and post-operative pain
management, today announced that the first patient was treated in
the HEAL-IST™ trial (NCT 05280093). The first patient was treated
by Drs. Mark LaMeir and Carlo de Asmundis at University Hospital
Brussels. The HEAL-IST trial will evaluate the safety and
effectiveness of AtriCure’s Isolator® Synergy™ Clamp for the
treatment of drug-refractory patients diagnosed with Inappropriate
Sinus Tachycardia (IST). 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, multicenter, single-arm
study of 142 patients at up to 40 centers in the United States 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 Dr. LaMeir, Professor and
Head of Cardiac Surgery at University Hospital Brussels, and
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
Executive 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 mis-diagnosed,”
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.”
About AtriCure
AtriCure, Inc. provides innovative technologies for the
treatment of Afib and related conditions. Afib affects more than 33
million people worldwide. Electrophysiologists and cardiothoracic
surgeons around the globe use AtriCure technologies for the
treatment of Afib and reduction of Afib related complications.
AtriCure’s Isolator® Synergy™ Ablation System is the first medical
device to receive FDA approval for the treatment of persistent
Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System
products are the most widely sold LAA management devices worldwide.
AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure
that provides a lasting solution for long-standing persistent Afib
patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for
temporary ablation of peripheral nerves to block pain, providing
pain relief in cardiac and thoracic procedures. For more
information, visit AtriCure.com or follow us on Twitter
@AtriCure.
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Angie Wirick Investor Relations Chief Financial Officer (513)
755-5334 awirick@atricure.com
Valerie Storch-Willhaus Media Relations Vice President,
Corporate Marketing & Communications (612) 605-3311
vstorch-willhaus@atricure.com
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