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

Ablation Clinical Trial

— PROOF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293198
• Other study ID #: CLN-KODEX-0019
• Status: Completed
• Start date: November 4, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: EPD Solutions, A Philips Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 31, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ablation
• Atrial Fibrillation
• Atrium; Fibrillation

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
United States	John Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
EPD Solutions, A Philips Company

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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