On July 16th, 2011, Microport EP MedTech Co. Ltd. successfully completed the first-in-man clinical studies of the ColumbusTM 3D electrophysiological mapping system and VoyagerTM irrigated RF ablation catheter at Beijing Anzhen Hospital of the capital Medical University.
The clinical studies enrolled 10 patients with paroxysmal atrial fibrillation, who underwent the pulmonary vein isolation by RF catheter ablation under the guidance of the 3D Electrophysiological Mapping System. Linear ablations were performed at the isthmus after pulmonary vein isolation, with 100% acute pulmonary vein isolation success rate. No pulmonary vein stenosis was found during the immediate postoperative retrograde pulmonary vein angiography; and no complication occurred during or after the ablation procedures. This first-in-man clinical study paves the way for the upcoming large scale multi-center clinical trial.
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