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Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation

NCT04293198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2023-02-16

No results posted yet for this study

Summary

Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.

Conditions

  • Atrium; Fibrillation
  • Ablation

Interventions

DEVICE

KODEX-EPD System

The KODEX - EPD system is an open platform that uses any validated EP catheter to create real-time 3D images of the human heart. The KODEX occlusion viewer provides an indication of the occlusion status of the PV during cryoballoon PVI procedure

DEVICE

Fluoroscopy with contrast dye

Fluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures

Sponsors & Collaborators

  • EPD Solutions, A Philips Company

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2022-08-30
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States
  • Belgium

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 NCT04293198 on ClinicalTrials.gov