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All Inclusive Kodex - EPD Study

NCT05489445 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-11-02
Completion
2022-11-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489445 on ClinicalTrials.gov