All Inclusive Kodex - EPD Study

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: KODEX - EPD

• Registration Number: NCT05489445
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing EP	KODEX - EPD	Patients already clinically indicated for undergoing catheter-based eletrophysiological intervention, in which the FDA approved medical device KODEX-EPD system will be used.

Primary Outcome Measures

Name	Time	Method
Acute PVI during index procedure.	During EP	Use of segmental approach versus "one-shot" balloon application.
Long term efficacy	Up to 3 years post index procedure	Efficacy of PVI post index PVI

Secondary Outcome Measures

Name	Time	Method
Exploratory	Up to 5 years after first enrolled subject	Use of KODEX-EPD tissue characteristics to predict need for the segmental approach with cryoballoon

Trial Locations

Locations (1)

Banner - University Medical Center, Phoenix campus; 🇺🇸 Phoenix, Arizona, United States