AUSTIN, Texas, Oct. 12, 2015 /PRNewswire/ -- On October 9, 2015, Heart Hospital of Austin became the first facility in the United States to enroll patients in the FDA-approved AMAZE clinical trial to examine left atrial appendage (LAA) closure with the LARIAT Suture Delivery Device as an adjunct to ablation in patients with persistent and long-standing persistent atrial fibrillation (AFib). The first procedure was performed at Heart Hospital of Austin by David Tschopp, M.D., F.A.C.C., F.H.R.S., an electrophysiologist at Heart Hospital of Austin and with Austin Heart.
"This is a milestone in the treatment of atrial fibrillation," Dr. Tschopp said. "AFib is a life-changing disorder that causes devastating consequences, including stroke and congestive heart failure. Using the LARIAT device as an adjunct to conventional ablation could become the standard-of-care option for patients with persistent and/or long-standing persistent AFib. Current data suggests that a single ablation procedure of the pulmonary veins for treating AFib results in success rates between 20 to 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 provides complete closure and electrical isolation of the LAA without the risks associated with ablation, thus eliminating a potential source of AFib."
AFib is an irregular heartbeat, a rapid heartbeat or a quivering of the upper chambers of the heart, called the atria, due to a malfunction in the heart's electrical system. It is the most common heart rhythm disorder in the United States, affecting more than 5 million people. By not getting enough oxygen to the body, AFib can lead to heart and valve diseases, sleep apnea and chronic fatigue. In addition, AFib can lead to two potentially life-threatening conditions: stroke and congestive heart failure.
Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center, is an expert in the study of the role of the LAA in the triggering and maintenance of AFib.
"We are excited about being first in the U.S. to enroll in the AMAZE trial," Dr. Natale said. "Recent data in persistent AFib patients provide compelling evidence that sources are likely located outside of the pulmonary veins, the LAA being one of the most obvious. We have a number of studies that confirm the LAA as a site of initiating and maintaining AFib. The AMAZE trial enables us to study the benefits of complete electrical isolation, as well as mechanical isolation of the LAA in combination with pulmonary vein isolation ablation and will provide the data to demonstrate an AFib reduction benefit."
In a recently published study, the LARIAT used as an adjunct to ablation in patients with persistent or long-standing persistent AFib showed a 65 percent freedom from AFib at one year versus 39 percent in patients with ablation only. Other studies have demonstrated that the LARIAT device not only closes the LAA mechanically, but it can also isolate electrical activity within the LAA, a known trigger for AFib, shown to contribute abnormal electrical activity in a significant percentage of patients. The objective of the AMAZE trial is to demonstrate that the LARIAT will reduce or eliminate these LAA triggers and, when combined with pulmonary vein isolation (PVI) ablation, will lead to a reduced incidence of recurrent AFib compared to ablation alone, with a high safety profile.
The LARIAT is a permanent, non-implant solution to LAA closure that is being studied for its capabilities to both mechanically and electrically isolate the LAA in patients with AFib. The LARIAT utilizes remote suture delivery to close the LAA from the outside of the heart in a precise and controlled manner.
The AMAZE trial is a rigorously designed study approved by the U.S. Food and Drug Administration to validate the mechanical and electrical isolation benefits of the LARIAT device. The study is comprised of two stages. The overall study plan is to enroll a maximum of 600 persistent or longstanding 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 15 centers.
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Misty Whited or Kristin Marcum
Elizabeth Christian Public Relations
SOURCE Heart Hospital of Austin