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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552665
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : January 5, 2022
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Northwell Health

Study Description
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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
Cardiac Arrhythmia Device: KODEX-EPD system

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022
Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Images [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo a cardiac ablation
Criteria

Inclusion Criteria:

  • Cardiac Ablation

Exclusion Criteria:

  • There is no exclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552665


Contacts
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Contact: Ashley M Eapen 718-226-1997 aeapen@northwell.edu
Contact: Amanda Tice, RN 718-226-6454 atice@northwell.edu

Locations
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United States, New York
Staten Island University Hospital North Campus Recruiting
Staten Island, New York, United States, 10305
Contact: Marcin Kowalski, MD    718-226-4645    mkowalski1@northwell.edu   
Sponsors and Collaborators
Northwell Health
Philips Healthcare
Investigators
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Principal Investigator: Marcin Kowalski, MD Staten Island University Hospital North
More Information
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04552665    
Other Study ID Numbers: 20-0337
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes