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

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04552665

Collaborator

Philips Healthcare (Industry)

Enrollment

Location

23.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	Device: KODEX-EPD system

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 28, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cardiac Ablation

Exclusion Criteria:

There is no exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Staten Island University Hospital North Campus	Staten Island	New York	United States	10305

Sponsors and Collaborators

Northwell Health
Philips Healthcare

Investigators

Principal Investigator: Marcin Kowalski, MD, Staten Island University Hospital North

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Northwell Health

ClinicalTrials.gov Identifier:

NCT04552665

Other Study ID Numbers:

20-0337

First Posted:

Sep 17, 2020

Last Update Posted:

Jan 5, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Jan 5, 2022