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

1. Posterior ILPV to CS
2. Posterior LPV or 2a ILPV to SRPV
3. Anterior LPV
4. SLPV to LAA
5. SLPV to SRPV (Transverse Sinus)
6. IRPV to IVC (Atrial Isthmus)
7. Posterior RPV
8. Anterior RPV
9. a. SRPV to RA
   b. IRPV to RA
10. IVC to SVC