The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT05477602
• Lead Sponsor: CathVision ApS

Brief Summary

Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.

Detailed Description

A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.

Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.

The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Study Start: 2023-01-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
• Male or non-pregnant female aged ≥ 21 years.
• Able and willing to provide written informed consent prior to any clinical investigation related procedure.

Exclusion Criteria

• Current participation in another investigational drug or device study that interferes with this study.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• Life expectancy less than 12 month, in the opinion of the Investigator.
• Subjects who, in the opinion of the investigator, are not candidates for this study.
• Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physician feedback on algorithm performance	One day - day of procedure	Data collected during the study will be used to test a signal complexity visualization algorithm evaluated as the technical success of the CathVision ECGenius System to collect and record intracardiac signals during ablation procedures for the treatment of persistent atrial fibrillation.

Secondary Outcome Measures

Name	Time	Method
Measurement of AF Cycle Length	One day - day of procedure	Data collected during the study will be used to test an AF cycle length algorithm

Trial Locations

Locations (1)

OLV Aalst; 🇧🇪 Aalst, Belgium