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

Terminated

• Conditions: Cardiac Arrhythmia
• Interventions: Device: KODEX-EPD system

• Registration Number: NCT04552665
• Lead Sponsor: EPD Solutions, A Philips Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Study Start: 2020-10-28
• Status Verified: 2023-06
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Cardiac Ablation

Exclusion Criteria

• There is no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults	KODEX-EPD system	Patients who have cardiac arrhythmia

Primary Outcome Measures

Name	Time	Method
Cardiac Images	Through study completion, an average 1 year	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.

Trial Locations

Locations (1)

Staten Island University Hospital North Campus; 🇺🇸 Staten Island, New York, United States