All Inclusive Kodex - EPD Study

Study Overview
=================
Brief Summary
-----------------
This is a post-market, prospective, observational study to evaluate the accuracy of KODEX 3D-imaging. The research study will collect pre-operative and post-operative cardiac imaging data from adult arrhythmia patients who are already undergoing catheter-based electrophysiological (EP) intervention (ablation procedures) using the FDA approved medical device KODEX - EPD™ system.

Detailed Description
-----------------
Atrial fibrillation (AF) is among the most prevalent arrhythmias in the world affecting approximately 1.5-2.0% of the general population. The age of patients with AF is steadily rising and now averages between 75 and 85 years of age. AF is associated with a five-fold risk of stroke, a three-fold incidence of congestive heart failure, and higher mortality. Symptoms arise from the rapid, irregular rhythm as well as the loss of cardiac pump function related to uncoordinated atrial contractions. These uncoordinated contractions also allow blood to pool in the atria and may ultimately lead to thromboembolism and stroke. AF is characterized by a chaotic contraction of the atrium in which an electrocardiogram (ECG) recording is necessary to diagnose the arrhythmia . The diagnosis requires an ECG demonstrating: (1) Irregular RR intervals (in the absence of complete AV block), (2) no distinct P waves on the surface ECG, and (3) an atrial cycle length (when visible) that is usually variable and less than 200 milliseconds. Initial therapy of atrial fibrillation is usually directed toward reversion to and maintenance of sinus rhythm through drug therapy. However, drug therapy can be associated with a number of unwanted effects such as proarrhythmia, long-term ineffectiveness, and even an increase in mortality, especially in those with impaired ventricular function. In the treatment of Atrial Fibrillation (AF) catheter ablation is considered superior regarding freedom of arrhythmia recurrence compared to anti-arrhythmic drug therapy. , , . Intracardiac ablation has been developed using a technique of pulmonary vein isolation (PVI) to disconnect the rapid firing of the pulmonary veins from the rest of the left atrium. Current guidelines recommend PVI by means of catheter ablation as treatment for symptomatic drug-refractory paroxysmal AF . Radiofrequency and cryoballoon catheters are the most frequently utilized ablation modalities. It has been demonstrated that cryoballoon ablation is non-inferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal AF, and there were no differences with regard to overall safety. Current catheter-based therapy utilizes cardiac 3D mapping and navigation systems that were introduced more than 20 years ago and allow location of the ablation device within a reconstruction of the heart anatomy , , , . However, technical limitations specific to each available 3D mapping system, such as variability in catheter tip location sensing, alternating location reliability throughout the procedure, and the use of costly specialized catheters and additional hardware (e.g. magnets placed under the operating table, pose limitations of these systems. Furthermore, all available systems provide only an estimate of each individual anatomy, as they do not provide high-quality, real-time visualization of anatomical structures, but merely a low-resolution reconstruction. In order to obtain more information and a precisely detailed anatomy, time consuming and often costly additional imaging such as fluoroscopy, angiography, echocardiography and even pre-procedural computer tomography (CT) and magnetic resonance imaging (MRI) is required in many cases. In conclusion the current procedures are relatively long, considered highly complex and require substantial expertise. In addition, specialized catheters and additional hardware are required. The manufacturer has identified these challenges and has developed the KODEX - EPD system to address them.

Official Title
-----------------
Evaluating KODEX-EPD Electrophysiology Mapping During Cryoballoon Pulmonary Vein Isolation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: KODEX - EPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old Documented atrial fibrillation Exclusion Criteria: Prior history left atrial catheter ablation and/or surgical maze procedure Pregnancy as confirmed with positive blood test at index procedure Prior history of congenital heart condition resulting in anomalous pulmonary vein anatomy left ventricular ejection fraction less than or equal to 35%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing EP<br>Patients already clinically indicated for undergoing catheter-based eletrophysiological intervention, in which the FDA approved medical device KODEX-EPD system will be used. | Device: KODEX - EPD<br>* A patient that is already clinically indicated to undergo cryoballoon ablation for atrial fibillation will use the The KODEX - EPD™ Cardiac Imaging and Navigation electrophysiological (EP) System. This is an imaging system which allows the physician real-time visualization of the catheters in a patients heart during the procedure, as well as display of cardiac images of the patients heart in a number of different formats. The KODEX - EPD system used in this study is cleared for commercial use by the FDA and therefore, it's use in this study constitutes as standard clinical use.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute PVI during index procedure. | Use of segmental approach versus one-shot balloon application. | During EP | 
| Long term efficacy | Efficacy of PVI post index PVI | Up to 3 years post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory | Use of KODEX-EPD tissue characteristics to predict need for the segmental approach with cryoballoon | Up to 5 years after first enrolled subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
irregular heart beat, rapid heart beat, Cryoballoon ablation, Cardiac Imaging, 3D mapping, Afib ablation, Atrial fibrillation, Pulmonary vein isolation, 3D mapping of the heart