Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature

Status Completed

Clinical Trial 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.

Clinical Trial Description

The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. The study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen ensuring a minimal burden to the subjects participating in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04293198
Study type	Observational
Source	EPD Solutions, A Philips Company
Contact
Status	Completed
Phase
Start date	November 4, 2020
Completion date	January 31, 2023

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms