Houston, TX (June 21, 2016) – St. Luke’s Health–Baylor St. Luke’s Medical Center (Baylor St. Luke’s) announced today that it’s the first hospital in the Greater Houston area to enroll patients in the AMAZE clinical trial, which studies a new experimental alternative for patients with persistent and longstanding atrial fibrillation (AFib).
The objective of the AMAZE trial is to demonstrate that using the LARIAT Suture Delivery Device for left atrial appendage (LAA) closure, plus pulmonary vein isolation (PVI) catheter ablation will lead to a reduced incidence of recurrent AFib compared to PVI alone (the current gold-standard treatment). Current data suggests that a single ablation procedure of the pulmonary veins for treating persistent or long standing persistent AFib results in success rates between 20-40 percent. However, the LAA is a known trigger of AFib, but is rarely isolated due to risks of ablating this fragile structure. The LARIAT device, a permanent, non-implant solution to LAA closure, provides complete closure and electrical isolation of the LAA without the risks associated with ablation, thus eliminating a potential source of AFib.
“We’re excited about being first in Houston to participate in the AMAZE trial. Recent data in persistent AFib patients provides compelling evidence that sources of the arrhythmia are likely located outside the pulmonary veins— the LAA being one of the most obvious,” Abdi Rasekh, MD, Director of the Electrophysiology Service Line at Baylor St. Luke’s and Associate Professor of Cardiology, Baylor College of Medicine. The AMAZE trial enables us to study the benefits of complete electrical isolation, as well as mechanical isolation of the LAA in combination with PVI ablation and will provide the data to demonstrate an AF reduction benefit.”
With more than 5 million people affected in the United States, atrial fibrillation is the most common type of heart arrhythmia1. An arrhythmia occurs when the heart beats too slowly, too fast, or irregularly due to a malfunction in the heart’s electrical system. AFib can lead to increased risk of stroke and heart failure, as well as chronic fatigue.
“This could be a potential milestone in the treatment of atrial fibrillation,” said Dr. Rasekh. “AFib is a life-changing disorder that causes devastating consequences including stroke and congestive heart failure. Using the LARIAT device as an assistant to conventional ablation could become the standard of care option for patients with persistent AFib.”
The overall plan for the AMAZE study is to enroll a maximum of 600 persistent or long-standing persistent AFib patients who are candidates for PVI catheter ablation at up to 50 centers. The first stage of the AMAZE trial will enroll up to 175 patients at 35 centers.
About St. Luke’s Health
St. Luke’s Health, a member of Catholic Health Initiatives (CHI), is comprised of three markets, St. Luke’s Health is home of the Texas Heart Institute (THI), eight hospitals, eight emergency centers, Diagnostic & Treatment Center, Radiation & CyberKnife® Center, and several St. Luke’s Medical Group locations throughout Greater Houston; St. Luke’s Health Memorial (three hospitals and a long-term acute care facility in East Texas); and St. Joseph Health (five hospitals and several St. Joseph Medical Group locations across Brazos Valley). In addition, St. Luke’s is a part of a joint venture agreement with Baylor College of Medicine®, which encompasses Baylor St. Luke’s Medical Center in the Texas Medical Center. Together, St. Luke’s Health, THI, and Baylor College of Medicine® are transforming healthcare delivery with a mission to usher in a new era of healthcare to create healthier communities. For more information, visit CHIStLukesHealth.org.
St. Luke’s Health is a part of Catholic Health Initiatives (CHI), one of the nation’s largest health systems. Headquartered in Englewood, Colorado, CHI operates in 19 states and comprises 105 hospitals, including four academic medical centers and teaching hospitals; 30 critical-access facilities; community health services organizations; accredited nursing colleges; home health agencies; and other services that span the inpatient and outpatient continuum of care. Learn more at catholichealthinitiatives.com.
1Waktare JEP. Atrial fibrillation. Circulation. 2002; 106: 14-16