AGA Medical has received conditional investigational device exemption (IDE) approval from FDA to evaluate the safety and efficacy of its Amplatzer Cardiac Plug (ACP) to close the left atrial appendage.
The trial was designed to demonstrate efficacy in preventing stroke in atrial fibrillation patients who are eligible to receive Warfarin, as well as safety of the device and the procedure.
The ACP clinical study is a multi-center 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.
AGA Medical said that the interim analysis 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 analysis will determine when the trial has achieved its endpoints and if AGA Medical is able to conclude the trial prior to enrolling 2,000 patients.
The trial design includes a feasibility phase to be followed by a pivotal phase. The results of the feasibility phase, which consists of the first 30 patients to receive the ACP, will serve to further validate safety conclusions demonstrated through pre-clinical testing.
The patients will be followed for 45 days after the procedure and evaluated for adverse events. The 45-day feasibility data will be reviewed by an independent data safety monitoring board prior to FDA review. Additional subjects will be enrolled in the pivotal phase of the trial after the FDA has completed its review.
AGA Medical said that the Amplatzer Cardiac Plug had received European CE Mark approval in December 2008, and is currently sold in Europe, South America and parts of the Pacific Rim.
John Barr, president and chief executive officer of AGA Medical, said: “Approval of the study will allow us to further evaluate our approach to reducing strokes in patients with atrial fibrillation by using our Amplatzer Cardiac Plug to permanently seal the appendage, hopefully sparing patients from spending the rest of their lives on anticoagulants.”