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)

Why Participate in the nContact CAP STOPS AF Clinical Trial?
nContact's study hypothesis is that a combined ablation AF procedure using the Numeris® - AF Guided Coagulation System with VisiTrax® and a commercially available catheter may offer a treatment solution for drug refractory symptomatic paroxysmal AF patients.

You may be eligible to participate in the clinical trial:

• If you are between 18 and 80 years of age
• You have documented drug refractory symptomatic paroxysmal AF
• You have had to stop taking at least one anti arrhythmia medication

You are not eligible to participate:

• If you need another cardiac surgery such as bypass graft or a heart valve repair or replacement
• If you have had a previous catheter ablation for AF
• If you have had a previous cardiac surgery

These are the preliminary eligibility criteria to enroll in the study and receive the study procedure for your drug refractory symptomatic paroxysmal AF. To further evaluate your eligibility for study participation, contact your physician or the nearest nContact clinical trial site.

What are the risks of clinical trial participation?
Your physician is the most appropriate person to discuss the risks of this study procedure and other treatment options for your AF.

For information on nContact clinical trials, please contact:

Jagruti Vyas 
Director of Clinical Studies
nContact, Inc.
919-655-1354 
jvyas@ncontactinc.com