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Status:

TERMINATED

Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study

Lead Sponsor:

EPD Solutions, A Philips Company

Conditions:

Arrythmia

Eligibility:

All Genders

18+ years

Brief Summary

Study to evaluate the safety and procedural performance of the KODEX - EPD System when used in the treatment of cardiac arrhythmias. An additional objective is to develop patient specific optimized th...

Detailed Description

PSOT PMCF is a prospective, multi-center, non-randomized, open label, single arm observational/ registry clinical study. Consented subjects who are scheduled to undergo an ablation procedure due to an...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • . Subjects who are eligible for an ablation procedure based on local guidelines,
  • . Subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws
  • . Subjects must be able and willing to comply with all follow-up requirements
  • Exclusion Criteria
  • . Women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator),
  • . Life expectancy less than 12 months,
  • . Participation in a concurrent clinical study without prior approval from EPD Solutions.
  • . Any contra-indication to use KODEX-EPD System per User Manual.
  • . Unrecovered/unresolved adverse events from any previous invasive procedure

Exclusion

    Key Trial Info

    Start Date :

    November 30 2018

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 30 2023

    Estimated Enrollment :

    566 Patients enrolled

    Trial Details

    Trial ID

    NCT03481413

    Start Date

    November 30 2018

    End Date

    March 30 2023

    Last Update

    June 8 2023

    Active Locations (22)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (22 locations)

    1

    Dignity Health Research Institute

    Sacramento, California, United States, 95819

    2

    Northwestern Memorial Hospital

    Chicago, Illinois, United States, 60611

    3

    Johns Hopkins University

    Baltimore, Maryland, United States, 21287

    4

    NYU Langone Health

    New York, New York, United States, 10016