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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: KODEX-EPD system

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

• Study Contact: Name: Ashley M Eapen; Phone Number: 718-226-1997; Email: aeapen@northwell.edu
• Study Contact Backup: Name: Amanda Tice, RN; Phone Number: 718-226-6454; Email: atice@northwell.edu

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital North Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo a cardiac ablation

Description

Inclusion Criteria:

• Cardiac Ablation

Exclusion Criteria:

• There is no exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults; Patients who have cardiac arrhythmia	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: EPD Solutions, A Philips Company
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Marcin Kowalski, MD, Staten Island University Hospital North; Study Director: Anneleen Viville, EPD Solutions, A Philips Compagny

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 20-0337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No