Convergent Trial - Longstanding Persistent AF
Eligibility	Sponsor Information
Lead Investigator	Animation Video

CAP STOPS LSP-AF

Combined Ablation Procedure For the Treatment of Longstanding Persistent Atrial Fibrillation

Purpose

nContact Inc. is evaluating the safety and efficacy of a combined epicardial (outer surface of heart tissue) /endocardial (inner surface of the heart tissue) beating heart ablation procedure without chest incisions or ports for the treatment of longstanding persistent atrial fibrillation using the investigational Numeris^® - AF Guided Coagulation System with VisiTrax^® and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter.

The goal of the study is to restore sinus rhythm and eliminate the dependence on anti-arrhythmic drugs.

Features of the Numeris^® - AF Guided Coagulation System with VisiTrax^® 

• Endoscopic access to the posterior of the heart allowing direct visualization of lesion creation
• Constant contact with cardiac tissue regardless of cardiac anatomy
• Precise visible lesion creation without damage to surrounding tissue
• Continuous and complete lesions allow the creation of a comprehensive bi-atrial lesion pattern
• Ability to coagulate tissue epicardially on a beating heart without any chest incisions, ports, or deflation of the lungs

Study Procedure

The clinical trial involves creating a comprehensive epicardial /endocardial bi-atrial lesion pattern on the outer and inner surface of a beating heart that blocks electrical signals that cause AF. The epicardial lesions are created using nContact's Numeris^® - AF Guided Coagulation System with VisiTrax^® on both the left and right atria, the upper chambers of the heart, where the AF occurs. The endocardial lesions are created using the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter.

Epicardial Lesions 1.  Left Posterior Atrial Roof Lesions Left atrial roof from LPV to RPV; Posterior RPV towards the inferior vena cava 1b.  Left pulmonary vein to Coronary       Sinus Lesion 2.  Right Anterior Pulmonary Vein Lesion 3.  Left Anterior Pulmonary Vein Lesion Endocardial Lesions 4.  Left Superior Pulmonary Vein      interconnecting lesion. 5.  Right Superior Pulmonary Vein       interconnecting lesion. 6.  Right Inferior Pulmonary Vein      interconnecting lesion. 7.  Cavotricuspid Isthmus Lesion 8.  Coronary Sinus Lesion