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

Completed

• Conditions: Ablation; Atrium; Fibrillation
• Interventions: Device: KODEX-EPD System; Device: Fluoroscopy with contrast dye

• Registration Number: NCT04293198
• Lead Sponsor: EPD Solutions, A Philips Company

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Study Start: 2020-11-04
• Primary Completion: 2022-08-30
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kodex arm	KODEX-EPD System	Cryoballoon PVI where the freeze was initiated based on the outcome of the KODEX occlusion Viewer
control arm	Fluoroscopy with contrast dye	Cryoballoon PVI procedure where the freeze was initiated based on the occlusion assessed using fluoroscopy

Primary Outcome Measures

Name	Time	Method
Freeze success of the KODEX-EPD Occlusion Viewer	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.
Effectiveness of the KODEX-EPD Occlsuion Viewer	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.

Trial Locations

Locations (2)

UZ Brussel; 🇧🇪 Brussel, Belgium

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States