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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrium; Fibrillation, Ablation

Intervention / Treatment
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* Device: KODEX-EPD System
* Device: Fluoroscopy with contrast dye


Participation Criteria
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Eligibility Criteria
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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: 1. Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control arm<br>Cryoballoon PVI procedure where the freeze was initiated based on the occlusion assessed using fluoroscopy | Device: Fluoroscopy with contrast dye<br>* Fluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures<br>|
| Kodex arm<br>Cryoballoon PVI where the freeze was initiated based on the outcome of the KODEX occlusion Viewer | Device: KODEX-EPD System<br>* 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<br>* Other names: KODEX Occlusion Viewer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to approximately 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, AF, Cryoballoon, Ablation, KODEX-EPD