NCT05458648

Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm

A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: CathVision ApS · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To acquire, amplify, digitize, and record atrial intracardiac electrophysiology signals during cardiac electrophysiology studies for the treatment of persistent atrial fibrillation and to use the recorded data to test the performance of an signal complexity visualization algorithm.

Detailed description

A prospective, single-center, pilot study using the CathVision ECGenius® system and the Ablation Impact Analyzer software in radiofrequency (RF) ablation procedures. Subjects with persistent atrial fibrillation who are indicated to undergo an RF ablation to treat persistent AF may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational ECGenius® System in parallel with the commercial (FDA Approved) EP Workmate, Abbott Inc. EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The CathVision ECGenius system allows physicians and users to record intracardiac electrograms during human electrophysiological studies including treatments for atrial fibrillation and atrial tachycardias. Improvements to the first-generation system are in development and include software features and algorithms for further analysis and description of signals to improve the clinical utility of the recorded signals. These new algorithms and software features require leveraging clinical use data as part of the development and iteration process. This study will allow the evaluation of algorithms for advanced signal analysis in a low-risk clinical setting by recording raw electrocardiograms during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial tachycardias and atrial fibrillation. The data will be recorded by a conventional market-approved EP recording system and on a parallel investigational CathVision ECGenius system for subsequent offline prototype analysis. Information from the investigational system and algorithms will not be available to the physician during the treatment and will have no diagnostic or therapeutic impact on the clinical case. The validation of the automated algorithm will be performed offline.

Conditions

• Persistent Atrial Fibrillation
• Cardiac Arrhythmia

Interventions

Type	Name	Description
PROCEDURE	Cardiac Ablation for the treatment of persistent Atrial Fibrillation	Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.

Timeline

• Start date: 2022-07-28
• Primary completion: 2023-10-30
• Completion: 2024-12-31
• First posted: 2022-07-14
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

1 site across 1 country: United States