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

NCT03481413 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 566

Last updated 2023-06-08

No results posted yet for this study

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 therapy (PSOT PMCF) via machine learning to improve future treatment of cardiac arrhythmias (PSOT).

Conditions

  • Arrythmia

Interventions

DEVICE

Ablation

Ablation therapy for cardiac arrhythmias

Sponsors & Collaborators

  • EPD Solutions, A Philips Company

    lead INDUSTRY

Principal Investigators

  • Anish Amin, MD · OhioHealth Riverside Methodist Hospital

  • Yitschak Biton, MD · Hadassah Medical Organization

  • Min Tang, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2023-03-30
Completion
2023-03-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481413 on ClinicalTrials.gov