Concomitant Trial for the Treatment of Longstanding Persistent AF using the Investigational Numeris®-AF Tethered Coagulation System with VisiTrax®

Purpose
nContact Inc. is conducting this trial to evaluate the safety and efficacy of the treatment of longstanding persistent AF using the Numeris® - AF Tethered Coagulation System with VisiTrax® in patients scheduled for open heart surgery.

The goal of the study is to restore sinus rhythm and eliminate the dependence on anti-arrhythmic drugs.
Features of the Numeris® - AF Tethered Coagulation System with VisiTrax®

• 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 allows the procedure to be completed 
  on a beating heart

Study Procedure
The clinical trial involves creating a comprehensive bi-atrial lesion pattern on a beating heart that blocks electrical signals that cause AF. The lesions are created using nContact's Numeris® - AF Tethered Coagulation System with VisiTrax® on both the left and right atria, the upper chambers of the heart, where the AF occurs.

Epicardial Lesions  Posterior ILPV to CS Posterior LPV or 2a ILPV to SRPV Anterior LPV SLPV to LAA SLPV to SRPV (Transverse Sinus) IRPV to IVC (Atrial Isthmus) Posterior RPV Anterior RPV a. SRPV to RA b. IRPV to RA IVC to SVC

 

Why Participate in the nContact Numeris® - AF Tethered Coagulation System Clinical Trial?
nContact's study hypothesis is that the study AF procedure using the Numeris® - AF Tethered Coagulation System with VisiTrax® may offer a treatment solution for longstanding persistent AF patients.

About the Trial

The study will be conducted at 15 study sites across the United States. 107 eligible participants from these trial sites will receive the AF treatment.

You may be eligible to participate in the clinical trial:

• If you are between 18 and 80 years of age
• If you have documented longstanding persistent AF for less than 10 years
• If you are scheduled for heart surgery such as bypass surgery or valve repair/replacement

You are not eligible to participate:

• 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