The FDA has approved an investigational device exemption for a clinical trial to assess the safety and efficacy of a combined surgical and catheter procedure (the convergent procedure) to treat patients with longstanding persistent atrial fibrillation (AF).
According to the Morrisville, N.C.-based nContact, the Numeris-AF Guided Coagulation System with VisiTrax will be used in combination with St. Jude Medical's Cool Path Ablation Catheter.
During the multicenter, prospective trial, researchers will evaluate the safety of the convergent procedure performed by a cardiac surgeon and an electrophysiologist. The team will perform a closed chest epicardial ablation and endocardial catheter-based ablation procedure.
According to nContact, the trial will measure freedom of AF and Class I and III anti-arrhythmic drugs as its primary endpoints.
The convergent procedure is less invasive, alleviating the need for chest ports or incisions, and instead using mapping and diagnostic endpoints to measure completion.
Currently, the Numeris system is approved for use by the FDA for the coagulation of cardiac tissue. In addition, the system gained a CE Mark of approval by the European Union for the treatment of AF and atrial flutter.