Convergent Trial - Paroxysmal AF
Eligibility	Sponsor Information
Lead Investigator	Animation Video

CAP STOPS AF

Combined Ablation Procedure For the Treatment of Paroxysmal 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) ablation procedure without chest incisions or ports for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation using the investigational Numeris- AF Guided Coagulation System with VisiTrax and a commercially available 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 a commericially available ablation catheter.

Epicardial Lesions 1.  Posterior Pericardial Reflection      Lesion Posterior LPV to left atrial roof Left atrial roof from LPV to RPV Posterior RPV towards the inferior vena cava 2.  Anterior Right Pulmonary Vein Lesion 3.  Anterior Left Pulmonary Vein Lesion Endocardial Lesions 4.  Left Superior Pulmonary Vein      connecting Lesion. 5.  Right Superior Pulmonary Vein       connecting Lesion. 6.  Right Inferior Pulmonary Vein      connecting Lesion. Cavotricuspid Isthmus Lesion (For patients with a history of, or inducible typical atrial flutter)