FDA approves expansion of Ablation’s atrial fibrillation trial

Approval from the FDA to proceed with the pivotal phase of the study is based on the review of an initial feasibility segment completed in August 2007. The study, known as the Tailored Treatment of Permanent Atrial Fibrillation (TTOP AF), uses an approach that allows cardiologists to customize their treatment strategy and potentially shorten procedure times, improve patient outcomes, and reduce recurrence of the disease.

Patients will initially be randomized into two treatment groups; one group receiving ablation therapy, and the other group called the control arm, receiving commonly used drug treatments. For every two patients initially receiving an ablation, one will be randomly assigned to the control arm. The trial allows patients in the control arm to receive an ablation if they do not respond to drug therapy. At the conclusion of the study, Ablation Frontiers will submit a pre-market approval application to the FDA for marketing the Catheter Ablation System in the US.

Keegan Harper, CEO of Ablation Frontiers, said: “The pivotal phase of the TTOP AF trial is designed to demonstrate the clinical safety and efficacy of our Catheter Ablation System as compared to current drug options.”