All Inclusive Kodex - EPD Study

Evaluating KODEX-EPD Electrophysiology Mapping During Cryoballoon Pulmonary Vein Isolation

Sponsors

Lead Sponsor: University of Arizona

Source 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.

Overall Status Recruiting
Start Date 2021-09-15
Completion Date 2024-08-01
Primary Completion Date 2024-08-01
Study Type Observational
Primary Outcome
Measure Time Frame
Acute PVI during index procedure. During EP
Long term efficacy Up to 3 years post index procedure
Secondary Outcome
Measure Time Frame
Exploratory Up to 5 years after first enrolled subject
Enrollment 30
Condition
Intervention

Intervention Type: Device

Intervention Name: KODEX - EPD

Description: 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.

Arm Group Label: Patients undergoing EP

Eligibility

Sampling Method:

Non-Probability Sample

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%

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Michael Fallon, M.D. Study Director University of Arizona
Overall Contact

Last Name: Anna Valencia, MPH

Phone: 520-780-8241

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Banner - University Medical Center, Phoenix campus Jessica Winters, MLS 520-780-1882 [email protected]
Location Countries

United States

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Arizona

Investigator Full Name: Wilber Su

Investigator Title: Clinical Associate Professor, Cardiology

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Patients undergoing EP

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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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