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

NCT05477602 | Completed Results

• 1 other identifier: CVAR-00002-A
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

electrophysiology; cardiac ablation; persistent atrial fibrillation; cycle length

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Cardiac Ablation for the treatment of persistent Atrial Fibrillation PROCEDURE

Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation

Also known as: Persistent AF Ablation

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for a cardiac ablation for the treatment of persistent atrial fibrillation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CathVision ApS: lead

Study Sites (1)

OLV Aalst

Aalst, 9300, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Karl Firth
• Organization: CathVision ApS

kpf@cathvision.com

0702097102

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: January 16, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)