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

NCT04293198 | Completed FDA Device

• 1 other identifier: CLN-KODEX-0019
• Study Type: observational
• Target: 63
• Locations: 2 countries
• Sites: 2

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.

Conditions

Atrium; Fibrillation; Ablation

Keywords

Atrial Fibrillation; AF; Cryoballoon; Ablation; KODEX-EPD

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

control arm

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

Device: Fluoroscopy with contrast dye

Kodex arm

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

Device: KODEX-EPD System

Interventions

KODEX-EPD System 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

Also known as: KODEX Occlusion Viewer

Kodex arm

Fluoroscopy with contrast dye DEVICE

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

control arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Arrhythmia patients scheduled to undergo a cryo balloon ablation procedure for their atrium fibrillation. Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study

You may qualify if:

• Subject must be aged \>18 years.
• Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
• Subject must be willing to comply with the protocol requirements.
• Subject receives a de novo ablation procedure for treatment of atrial fibrillation.

You may not qualify if:

• \. Pregnant women.

Sponsors & Collaborators

• EPD Solutions, A Philips Company: lead

Study Sites (2)

John Hopkins University

Baltimore, Maryland, 21205, United States

Location

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Fluoroscopy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 3, 2020
• Study Start: November 4, 2020
• Primary Completion: August 30, 2022
• Study Completion: January 31, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

BE (1); US (1)