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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05301803
• Other study ID #: CP-00003-A
• Status: Completed
• Start date: March 29, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: CathVision ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• Electrophysiology procedure
Electrophysiology testing and cardiac ablation of arrhythmia

Locations

Country	Name	City	State
United States	The University of vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
CathVision ApS	Medicept Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracardiac signal collection	Technical success of CathVision ECGenius® system to collect and record intracardiac signals during EP procedures	EP and ablation procedures can take up to six hours
Primary	Low voltage electrogram	Ability of CathVision ECGenius to collect low voltage electrograms of less than 20uV in different cardiac rhythms	EP and ablation procedures can take up to six hours
Primary	Freedom from major adverse events, evaluated at hospital discharge	Freedom from major adverse events, evaluated at hospital discharge	From EP procedure to discharge is usually one day.