Skip to main content
OpenTrials
Completed

NCT Number: NCT05301803

An Evaluation of the Safety and Performance of the CathVision ECGenius® System.

The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of vermont

Burlington, Vermont, 05401, United States

About this study

A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.

Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
  • At least 18 years of age.
  • Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

Exclusion criteria

  • Patient inability to understand or refusal to sign informed consent.
  • Patient is a prisoner or under incarceration
  • Patients who in the opinion of the physician are not candidates for this study.

Treatment and study plan

Electrophysiology procedure

Device

Electrophysiology testing and cardiac ablation of arrhythmia

Primary outcomes

  1. Baseline Noise Comparison

    Time frame: EP and ablation procedures can take up to six hours

    Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV

  2. Freedom From Major Adverse Events, Evaluated at Hospital Discharge

    Time frame: From EP procedure to discharge is usually one day.

    Freedom from major adverse events, evaluated at hospital discharge

    Adverse events were categorized as one of:

    An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device.

    A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE.

    An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Sponsors and collaborators

Lead sponsor

CathVision ApS

Industry

Collaborators

  • Medicept Inc.

Registry information

Official study title

A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius® System.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.