SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage.
Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA approved an expansion of the study, which can now enroll another 500 patients after an independent data monitoring committee reviewed the data against preset safety and performance criteria, Redwood City, Calif.-based SentreHeart said.
SentreHeart can enroll as many as 500 more patients for the 2nd, pivotal stage, according to ClinicalTrials.gov. The primary endpoints are freedom from afib episodes of more than 30 seconds after a year, with a secondary endpoint of freedom from afib episodes of more than 30 seconds, with or without anti-arhythmic drugs, from the 90-day mark to 1 year. Other endpoints include a composite of any-cause stroke and systemic embolism at 12 months, technical success at 12 months defined as ≤1 ± 1mm diameter residual communication with the left atrium.
The Amaze trial’s estimated completion date is December 2018, with a final data collection for the primary outcome slated for October 2018, according to the website.
“We are pleased with both the [data monitoring committee] and FDA’s endorsement of the Amaze trial’s interim safety and performance which allow us to expand to stage 2 of the Trial. With FDA’s approval, we can seamlessly expand to additional centers and continue patient enrollment without interruption,” president & CEO Russell Seiber said in prepared remarks. “The Amaze trial is groundbreaking in its therapeutic potential to improve outcomes in patients with afib and we look forward to completing the trial with our strong clinical investigator partnerships.”
“The Lariat procedure, when combined with PVI, may offer improved outcomes for patients with persistent and long-standing persistent afib, compared with PVI alone,” added study co-chairmen Drs. David Wilber and D.J. Lakkireddy, of Loyola University and the University of Kansas, respectively. “FDA approval to expand to stage 2 is an important step forward toward completion of this pivotal study.”