December 9, 2009 — A feasibility clinical trial was launched last week to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF).
This prospective, feasibility study will enroll patients at study sites across the United States. It includes paroxysmal patients with enlarged hearts, who historically have been more difficult to treat with catheter ablation in a single procedure. The study utilizes the nContact Numeris AF Guided Coagulation System with VisiTrax along with a commercially available ablation catheter, the Biosense Webster NaviStar ThermoCool Catheter. The combination of devices creates a standard, bi-atrial lesion pattern to block electrical signals that cause AF.
In addition, electrophysiologists have the capability to diagnostically ensure the lesion pattern is complete with pulmonary vein isolation. “We look forward to investigating this collaborative, interdisciplinary approach for the treatment of atrial fibrillation in patients with larger atria,” said Rodney Horton, M.D., principal investigator at St. David’s Medical Center in Austin, Texas.
The company said the convergent procedure is unique because lesions can be created on all areas of the heart through a closed chest endoscopic approach, without lung deflation, and while the heart is beating. The company said it is hoped that the combination of surgical and electrophysiology techniques will enhance physicians’ capability to ultimately treat all AF patients in a single procedure.
The Numeris Coagulation System with VisiTrax is based on the integration of suction, perfusion and RF energy to ensure the creation of visible, nonconductive, bi-atrial epicardial lesions on a beating heart. The system is indicated for the coagulation of cardiac tissue in the United States. nContact has initiated clinical studies for the treatment of AF in both open and closed chest procedures. The Numeris Coagulation System with VisiTrax has CE Mark approval in Europe for the specific indication for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.
For more information: www.ncontactsurgical.com