NCT04293198View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

63

Participants

Timeline

Start Date

November 4, 2020

Primary Completion Date

August 30, 2022

Study Completion Date

January 31, 2023

Conditions
Atrium; FibrillationAblation
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

Trial Locations (2)

1090

UZ Brussel, Brussels

21205

John Hopkins University, Baltimore

All Listed Sponsors
lead

EPD Solutions, A Philips Company

INDUSTRY

NCT04293198 - Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation | Biotech Hunter | Biotech Hunter