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

EPD Solutions

Status: Completed

Conditions: Ablation; Atrium; Fibrillation

Treatments: Device: Fluoroscopy with contrast dye; Device: KODEX-EPD System

Study type: Observational

Funder types: Industry

Identifiers

NCT04293198

CLN-KODEX-0019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

63 participants in 2 patient groups

control arm

Description:

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

Treatment:

Device: Fluoroscopy with contrast dye

Kodex arm

Description:

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

Treatment:

Device: KODEX-EPD System