SentreHeart said yesterday it won FDA investigational device exemption approval to begin enrolling subjects in a clinical trial of its Lariat device.
The Amaze trial will evaluate the use of the Lariat for the ligation of the left atrial appendage as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the company said.
“The LAA is an important site for atrial fibrillation initiation and persistence, and its exclusion using the Lariat device as an adjunct to conventional ablation could be a major breakthrough in decreasing recurrence in patients with persistent atrial fibrillation. The Amaze trial is rigorously designed and we believe will further validate the mechanical and electrical isolation benefits of the Lariat device, which has the potential to become a standard of care in treating persistent or longstanding persistent atrial fibrillation,” Dr. Dhanunjaya Lakkireddy of the University of Kansas Medical Center said in prepared remarks.
Studies of the Lariat have shown that it can isolate electrical activity within the left atrial appendage known to trigger atrial fibrillation, the Redwood City, Calif-based company said.
“SentreHeart was fortunate to be able to work closely with leading electrophysiologists and the FDA to ensure the Amaze Trial would address the most relevant clinical questions and endpoints required to advance the treatment of percutaneous solutions for persistent AFib. Our objective is to address improved treatment strategies for AFib of which the left atrial appendage plays a critical role in the restoration and maintenance of normal sinus rhythm, as well as protection against thromboembolism. The Amaze trial is key to fulfilling our commitment to developing clinical evidence that could greatly improve the lives of patients with atrial fibrillation,” CEO Russell Seiber said in a prepared statement.
The study is slated to enroll up to 600 patients with longstanding persistent atrial fibrillations at 50 centers, SentreHeart said. The 1st stage of the triall will enroll 175 patients, the company added.
In May, a study by researchers from the Texas Cardiac Arrhythmia Institute revealed a 20% rate of atrial leak development after 1 year in patients treated with SentreHeart’s Lariat ligation device.