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

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.

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Key information

Conditions

Atrium; Fibrillation Ablation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel, Brussels, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject must be aged >18 years.
Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
Subject must be willing to comply with the protocol requirements.
Subject receives a de novo ablation procedure for treatment of atrial fibrillation.

Exclusion criteria

Pregnant women.

Treatment and study plan

KODEX-EPD System

Device

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

Other names: KODEX Occlusion Viewer

Fluoroscopy with contrast dye

Device

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

Primary outcomes

Effectiveness of the KODEX-EPD Occlsuion Viewer

Time frame: up to approximately 6 months

The primary effectiveness endpoint is the accuracy, sensitivity, specificity and positive and negative predictive values of the KODEX-EPD PV occlusion feature as compared to conventional angiographic method of fluoroscopy with contrast dye that will be used to guide the procedure.
Freeze success of the KODEX-EPD Occlusion Viewer

Time frame: up to approximately 6 months

The success of the freeze when freeze is initiated based on the assessment of the KODEX-EPD PV occlusion feature as compared to the success of the freeze when freeze is initiated based on the assessment with fluoroscopy and contrast dye.

Sponsors and collaborators

Lead sponsor

EPD Solutions, A Philips Company

Industry

Registry information

Official study title

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

Acronym: PROOF

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Mar 3, 2020
Registry last updated: Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed