NCT05301803

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: CathVision ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
DEVICE	Electrophysiology procedure	Electrophysiology testing and cardiac ablation of arrhythmia

Timeline

• Start date: 2022-03-29
• Primary completion: 2022-04-30
• Completion: 2023-12-31
• First posted: 2022-03-31
• Last updated: 2024-09-05
• Results posted: 2024-09-05

Locations

1 site across 1 country: United States