nContact was founded to develop and evaluate medical devices for the minimally invasive treatment of arrhythmias. Based on the company’s mission, market surveys, and review of current medical practice for the treatment of AF, The Convergent Procedure was pioneered, resulting in closed chest, combined epicardial/endocardial US investigational IDE clinical trials. nContact has initiated the first Convergent Procedure clinical trial to evaluate the treatment of longstanding persistent AF. nContact has also initiated a second Convergent Procedure clinical trial to evaluate the treatment of symptomatic paroxysmal AF. 

The procedure is based on four unique features, which may make it a comprehensive and complete approach for treating longstanding persistent AF. Those four features include: 

1. Potential to be a treatment alternative for all types of AF
2. Combines the best surgical and electrophysiological (EP) techniques into one procedure
3. Only closed chest approach with complete, visible, cardiac access
4. Represents a comprehensive procedure with confirmed intra-operative diagnostic endpoints 

Combining the strengths of surgical and EP approaches provides a complete lesion pattern that is created and tailored to the patient’s needs. 

Surgical Approach. The surgical portion of the procedure allows surgeons to create long, linear ablation lesions (scar tissue) using the nContact investigational device. These lesions are connected into a bi-atrial lesion pattern under direct visualization. The primary physician criticism of catheter-only approaches is the inability to create long, linear ablation lesions, which is the reason catheter procedures can be time consuming (4-6 hours). 

EP Approach. The EP portion of the procedure ensures the lesion pattern is complete by the use of a catheter. Intra-operative EP mapping and diagnostic capabilities ensure isolation of the pulmonary veins and the posterior left atrium. Additionally, EPs can search and ablate other sources of errant electrical circuits outside of the lesion pattern. 

Thus, it is the multidisciplinary approach that is responsible for The Convergent Procedure’s completeness and making it a potential treatment alternative for longstanding persistent AF. 

nContact conducted a cardiology market survey to understand the AF patient population and therefore optimize enrollment in the IDE studies. The survey evidenced the need for a treatment alternative for longstanding persistent AF. 

1. Large Untreated Patient Population. Cardiologists, who supply most of the patient referrals to EPs, indicated that they see between 22-36 AF patients per week but only refer about 16% of patients to EPs, primarily paroxysmal patients. 
2. Limited Treatment Alternatives. The vast majority of patients not referred are treated with a combination of rate or rhythm control drugs, Coumadin, and cardioversion. Cardiologists estimated that approximately 63% of these patients were not satisfied with their treatment options. 
3. Need for Ablation Treatment in Longstanding Persistent Population. What was most telling was that 73% of cardiologists believed persistent and longstanding persistent patients needed an ablation treatment alternative. 
4. Traditional Surgical Approaches Not Acceptable to Cardiologists. It is very important that any new treatment be truly minimally invasive and exclude chest incisions, ports, and lung deflation, and be performed on a beating heart in the EP or hybrid lab. 
5. Cardiologists Agree With Combined Approach. When asked if they believed in the Convergent Procedure’s premise, 93% agreed with the premise of a combined surgical and EP approach for the longstanding persistent AF population. 

Thus, the cardiologist market survey indicated high interest for the Convergent Procedure in the IDE studies for the AF patient populations. 

Upon first look, when reviewing stand-alone treatment alternatives for AF in publications, it appears to be a very competitive landscape. Catheters, balloons, clamps, belts, cinches, and pens offer a wide variety of cardiac ablation treatment alternatives. A closer analysis indicates that the patient profiles from various technology trials are focused on a narrow, limited patient subset of the broader AF population. The chart below illustrates that the patient profiles are generally under 60 years of age, and have a left atrial size of less than 4.5 cm. This population does not generally have structural heart disease, and represents about 12-18% of the total AF population. 

Current reports of catheter or surgical approaches have demonstrated reasonable efficacy for symptomatic paroxysmal AF, made evident through clinical trials. One clinical trial resulted in the only FDA approved ablation catheter, the Biosense Webster® Thermocool®ablation catheter. However, stand alone surgical and catheter approaches are limited when focusing on longstanding persistent AF and patients with structural heart disease or enlarged atria (> 4.5 cm). 

The target population for The Convergent Procedure IDE clinical trials includes those patients with left atria greater than 4.5 cm, which generally indicates enlarged atria, and patients with a history of structural heart disease (e.g. hypertension, coronary artery disease, pulmonary disease, etc.). This patient population may benefit from treatment since population-based studies, shown below, have demonstrated these patients are at increased risk of adverse events compared to lone AF patients whose left atria do not become enlarged throughout long-term follow-up. 



The Convergent Procedure IDE clinical trials intend to evaluate different patient populations than have been studied previously. 88% of the general AF population consists of patients with enlarged atria and a history of structural heart disease*. Many of these patients have been relegated to living with AF while taking anti-arrhythmic drugs. This trial will hopefully provide insight into the ability for a single, multidisciplinary, closed chest procedure to prevent recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia without dependence on anti-arrhythmic drugs. 

* Fuster and Rydén et al. ACC/AHA/ESC Practice Guidelines. JACC Vol. 38, No. 4, October, 2001. 

The targeted patient populations for the IDE studies cover the majority of AF patients included in the 88% of the general AF population for whom there are limited stand alone ablation treatment options available. Patients who may be eligible for the nContact IDE studies: 

• Have symptomatic paroxysmal AF 
• Have longstanding persistent AF 
• Have a left atrial size less than 6.5 cm 
• Have not had previous cardiac surgery 
• Are between 18 and 80 years old