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Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance.

NCT04552665 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-06-08

No results posted yet for this study

Summary

The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.

Conditions

  • Cardiac Arrhythmia

Interventions

DEVICE

KODEX-EPD system

To evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D)

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • EPD Solutions, A Philips Company

    lead INDUSTRY

Principal Investigators

  • Marcin Kowalski, MD · Staten Island University Hospital North

  • Anneleen Viville · EPD Solutions, A Philips Compagny

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2023-06-06
Completion
2023-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04552665 on ClinicalTrials.gov