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

Last updated: February 21, 2025
Sponsor: CathVision ApS
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Atrial Fibrillation

Dysrhythmia

Treatment

Cardiac Ablation for the treatment of persistent Atrial Fibrillation

Clinical Study ID

NCT05477602
CathVision
  • Ages 21-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects undergoing RF ablation indicated by the investigator for the treatment ofpersistent atrial fibrillation.

  • Male or non-pregnant female aged ≥ 21 years.

  • Able and willing to provide written informed consent prior to any clinicalinvestigation related procedure.

Exclusion

Exclusion Criteria:

  • Current participation in another investigational drug or device study thatinterferes with this study.

  • Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation 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 anyvulnerable population.

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Cardiac Ablation for the treatment of persistent Atrial Fibrillation
Phase:
Study Start date:
January 16, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • OLV Aalst

    Aalst, 9300
    Belgium

    Site Not Available

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