NCT04293198

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: EPD Solutions, A Philips Company · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrium; Fibrillation
• Ablation

Interventions

Type	Name	Description
DEVICE	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
DEVICE	Fluoroscopy with contrast dye	Fluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures

Timeline

• Start date: 2020-11-04
• Primary completion: 2022-08-30
• Completion: 2023-01-31
• First posted: 2020-03-03
• Last updated: 2023-02-16

Locations

2 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated device study