Medtronic Announces Results of Ablation for Atrial Fibrillation Trial
Medtronic, Inc., has announced results of a clinical trial of its ablation system for patients with persistent atrial fibrillation.
Medtronic, Inc., today announced results from its Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF) clinical trial. The trial included 210 patients with persistent or long-standing persistent atrial fibrillation (AF) and compared the results of ablation therapy using the Medtronic Phased RF Ablation System with traditional therapy including antiarrythmic drugs and direct current cardioversion.
The trial found that 55.8% of patients receiving ablation management had an AF and atrial flutter burden reduction of greater than 90% and were free of antiarrhythmic drug therapy at six months, compared with 26.4% of those receiving traditional therapy. (Including those patients still receiving antiarrhythmic drugs, 67.4% of those receiving ablation management had a greater than 90% reduction of AF burden at six months.)
The acute safety event rate of the trial was 12.3% with an upper 95% confidence interval of 19%, which fell short of the pre-defined performance goal of 16%. In the trial, 12.3% of patients experienced one or more protocol-defined procedural and/or device-related adverse events within seven days of the procedure.
The 210 AF patients in the trial were randomized to receive either ablation treatment (138 participants) or traditional treatment (72 participants). Patients receiving ablation treatment were allowed to receive up to two ablations. Patients in both groups were followed at one, three, and six months.
There is a significant need for treatments for patients in the US with symptomatic, drug-refractory persistent AF. However, the only currently FDA-approved ablation therapies for AF are indicated for paroxysmal AF, not persistent AF (i.e., recurrent AF episodes that last more than seven days), which is more complex to treat. The Medtronic system is a percutaneous cardiac catheter and generator system designed to eliminate or isolate abnormal electrical impulses in the left atrium that initiate or sustain atrial fibrillation. It is currently approved for use in parts of Europe, Asia, and Africa, as well as Canada.
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