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

A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical 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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Electrophysiology procedure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients indicated for EP study or cardiac ablation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Noise Comparison	Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV	EP and ablation procedures can take up to six hours
Freedom From Major Adverse Events, Evaluated at Hospital Discharge	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.	From EP procedure to discharge is usually one day.

Collaborators and Investigators

• Sponsor: CathVision ApS
• Collaborators: Medicept Inc
• Investigators: Principal Investigator: Nathaniel C Thompson, MD PhD, The University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; electrophysiology; cardiac ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CP-00003-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No