All Inclusive Kodex - EPD Study

December 8, 2023 updated by: Wilber Su, University of Arizona

Evaluating KODEX-EPD Electrophysiology Mapping During Cryoballoon Pulmonary Vein Isolation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center, Phoenix campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patient population will be selected from patients undergoing EP study at BUMCP in either an inpatient or outpatient setting, then followed in the Banner Heart Institute.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing EP
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Study Director: Michael Fallon, M.D., University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

November 2, 2022

Study Completion (Actual)

November 2, 2022

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2103636199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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