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

NCT ID: NCT04552665

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-28

Study Completion Date

2023-06-06

Brief Summary

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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

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Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults

Patients who have cardiac arrhythmia

KODEX-EPD system

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cardiac Ablation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

EPD Solutions, A Philips Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcin Kowalski, MD

Role: PRINCIPAL_INVESTIGATOR

Staten Island University Hospital North

Anneleen Viville

Role: STUDY_DIRECTOR

EPD Solutions, A Philips Compagny

Locations

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Staten Island University Hospital North Campus

Staten Island, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-0337

Identifier Type: -

Identifier Source: org_study_id

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