SentreHeart Secures FDA Approval for Amaze Trial
The FDA has approved SentreHeart’s Amaze clinical trial evaluating the Lariat suture delivery system for closure of the left atrial appendage as an adjunct to ablation in patients with persistent or longstanding persistent atrial fibrillation.
The main objective of the study is to demonstrate that use of device in combination with pulmonary vein isolation ablation will reduce recurrent atrial fibrillation at a higher rate than PVI ablation alone, the Redwood City, Calif., devicemaker said Thursday. PVI ablation is the current standard of care.
The multicenter clinical trial will be split into two stages, with the first enrolling up to 175 patients across 15 centers. Eventually, patients will be treated at about 50 different centers.
The Lariat device has secured both FDA 510(k) marketing clearance and CE Mark certification. — Jason Scott