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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04552665
Acronym
KODEX
Enrollment
30
Registered
2020-09-17
Start date
2020-10-28
Completion date
2023-06-06
Last updated
2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Brief 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.

Interventions

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

Philips Healthcare
CollaboratorINDUSTRY
EPD Solutions, A Philips Company
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cardiac Ablation

Exclusion criteria

* There is no

Design outcomes

Primary

MeasureTime frameDescription
Cardiac ImagesThrough study completion, an average 1 yearThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026