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

Completed

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT05301803
• Lead Sponsor: CathVision ApS

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study Start: 2022-03-29
• Study First Posted: 2022-03-31
• Primary Completion: 2022-04-30
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline Noise Comparison	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
Freedom From Major Adverse Events, Evaluated at Hospital Discharge	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.

Trial Locations

Locations (1)

The University of vermont; 🇺🇸 Burlington, Vermont, United States