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

CathVision

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Cardiac Ablation for the treatment of persistent Atrial Fibrillation

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05477602

CVAR-00002-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design