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

EPD Solutions, A Philips Company63 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Atrium; Fibrillation Ablation

Interventions

KODEX-EPD SystemDEVICE

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

Fluoroscopy with contrast dyeDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject must be aged \>18 years. 2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures. 3. Subject must be willing to comply with the protocol requirements. 4. Subject receives a de novo ablation procedure for treatment of atrial fibrillation. Exclusion Criteria: 1\. Pregnant women.

Locations (2)

John Hopkins University

Baltimore, Maryland, United States

UZ Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Effectiveness of the KODEX-EPD Occlsuion Viewer

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.

Time frame: up to approximately 6 months

Freeze success of the KODEX-EPD Occlusion Viewer

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.

Time frame: up to approximately 6 months

Data from ClinicalTrials.gov

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