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NCT04552665 Clinical Trial

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

Cardiac Arrhythmia Clinical Trial

— KODEX  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04552665
Other study ID # 20-0337
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 28, 2020
Est. completion date June 6, 2023

Study information
Verified date June 2023
Source EPD Solutions, A Philips Company
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date June 6, 2023
Est. primary completion date June 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Cardiac Ablation Exclusion Criteria: - There is no exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
United States Staten Island University Hospital North Campus Staten Island New York

Sponsors (2)
Lead Sponsor Collaborator
EPD Solutions, A Philips Company Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Images 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. Through study completion, an average 1 year
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