The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System

Atrial Fibrillation Clinical Trial

Official title:

The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477602
• Other study ID #: CathVision
• Status: Recruiting
• Start date: January 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: CathVision ApS
• Contact: Tom De Potter, MD
• Phone: +32 53 724439
• Email: tomdepotter[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.

Description:

A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.

Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.

The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.

• Male or non-pregnant female aged = 21 years.

• Able and willing to provide written informed consent prior to any clinical investigation related procedure.

Exclusion Criteria:

• Current participation in another investigational drug or device study that interferes with this study.

• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

• Life expectancy less than 12 month, in the opinion of the Investigator.

• Subjects who, in the opinion of the investigator, are not candidates for this study.

• Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Cardiac Ablation for the treatment of persistent Atrial Fibrillation
Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst

Sponsors (2)

Lead Sponsor	Collaborator
CathVision ApS	AKRN Consulting

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician feedback on algorithm performance	Data collected during the study will be used to test a signal complexity visualization algorithm evaluated as the technical success of the CathVision ECGenius System to collect and record intracardiac signals during ablation procedures for the treatment of persistent atrial fibrillation.	One day - day of procedure
Secondary	Measurement of AF Cycle Length	Data collected during the study will be used to test an AF cycle length algorithm	One day - day of procedure