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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-04

Study Completion Date

2023-01-31

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.

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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.

Conditions

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Atrium; Fibrillation Ablation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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control arm

Cryoballoon PVI procedure where the freeze was initiated based on the occlusion assessed using fluoroscopy

Fluoroscopy with contrast dye

Intervention Type DEVICE

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

Kodex arm

Cryoballoon PVI where the freeze was initiated based on the outcome of the KODEX occlusion Viewer

KODEX-EPD System

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Fluoroscopy with contrast dye

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

Intervention Type DEVICE

Other Intervention Names

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KODEX Occlusion Viewer

Eligibility Criteria

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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.