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

You may be eligible to participate in the clinical trial:

• If you are between 18 and 80 years of age
• You have had longstanding persistent AF for less than 10 year
• You have symptons such as dizziness, irregular pulse, weakness, chest discomfort
• You have had to stop taking or change the dose or kind of medication for your AF

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 longstanding persistent 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