SentreHEART announced that it has completed the Stage I enrollment milestone in the aMAZE Trial.
The Trial aims to assess improved outcomes when the LARIAT Suture Delivery System (LARIAT) is used to close the left atrial appendage (LAA) in adjunct to Pulmonary Vein Isolation (PVI) catheter ablation in those patients that suffer from drug-refractory, persistent and long-standing persistent AFib.
Stage I of the aMAZE Trial is designed to assess safety and performance of the LARIAT procedure in the first 100 consecutively enrolled subjects, assessed by independent adjudication and data monitoring committees.
The first subject was enrolled into the aMAZE Trial in October 2015 and the Trial is currently recruiting subjects in 34 U.S. centers. It is anticipated that by mid 2017, the aMAZE Trial will expand to 50 centers across the U.S., and in limited international locations.
AFib is an irregular, rapid heartbeat or 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 sustained arrhythmia and a major global public health problem due to its associated morbidity, including stroke and heart failure, diminished quality of life, and increased mortality.
Approximately 33.5 million individuals worldwide suffer from AFib, with close to 5 million new cases occurring each year.
Studies have demonstrated the LARIAT not only closes the LAA mechanically1 but may also isolate electrical activity within the LAA2. Having a non-implant option that may both electrically and mechanically isolate the LAA is a potentially important addition to the treatment armamentarium for clinicians treating patients with persistent or longstanding persistent AFib. The LARIAT has the potential to eliminate the LAA as a source of AFib and nidus for thrombus.
Unlike other implant solutions for AFib, the aMAZE Trial seeks to potentially treat the underlying disorder of AF by mechanically and electrically isolating the base of the LAA using the percutaneous, non-implant LARIAT suture delivery device.
“We are delighted by the enrollment progress of the aMAZE Trial and are excited have achieved our 2016 enrollment objectives” says Russ Seiber, CEO, President and co-Founder.
“The rapid completion of this significant enrollment milestone demonstrates that clinicians and patients are seeking new therapeutic options for the treatment of persistent and long-standing persistent AFib.”
The aMAZE Trial is an FDA IDE-approved, prospective, multi-center, randomized controlled Trial evaluating the LARIAT Suture Delivery Device (LARIAT) for Left Atrial Appendage (LAA) closure adjunctive to Pulmonary Vein Isolation (PVI) catheter ablation for the treatment of persistent and long-standing persistent atrial fibrillation (AFib).
The objective of the AMAZE Trial is to demonstrate that the LARIAT for LAA closure, plus a pulmonary vein isolation (PVI) ablation will lead to a reduced incidence of recurrent AFib compared to PVI alone, with a high safety profile. The Trial will enroll up to 600 total subjects.
PVI Catheter ablation is the standard of care in the management of drug-refractory symptomatic AFib. However, the success rates of PVI ablation are less than ideal, especially in patients with persistent AFib3.
Current data suggests that a single ablation procedure of the pulmonary veins (PV) for treating AFib results in long-term success rates of only 20%-40%. The LAA has been known to play a role in triggering recurrence of AFib after treatment with PVI catheter ablation4, and is the source of most stroke-causing blood clots (thrombus) in AFib patients5.