AGA Medical Holdings has received conditional Investigational Device Exemption approval from the FDA to evaluate the safety and efficacy of its Amplatzer cardiac plug (ACP) to close the left atrial appendage.
The trial is designed to demonstrate efficacy in preventing stroke in atrial fibrillation patients who are eligible to receive warfarin (Coumadin, Bristol-Myers Squibb), as well as safety of the device and the procedure, according to the Minneapolis-based company.
AGA said its ACP study will be a multicenter trial with a two-to-one randomization between the ACP and medical management, warfarin, the current standard of care. The study design is based on a statistical method referred to as a Bayesian adaptive design with interim analyses that use observed efficacy and safety event rate data to predict the final sample size, probabilities for trial success and when the trial should be stopped.
Interim analyses will be performed after the first 400 patients are enrolled and at pre-determined periodic intervals thereafter, until a possible maximum of 2,000 patients are enrolled. These interval analyses will determine when the trial has achieved its endpoints and if AGA is able to conclude the trial prior to enrolling 2,000 patients. This trial design will include a feasibility phase to be followed by a pivotal phase.