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

NCT05458648 | Completed Results

• 1 other identifier: CVAR-00001-A
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Atrial Fibrillation; Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Ability to Collect CS Data

  Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient.

  One day - day of procedure

Secondary Outcomes (1)

• Measurement of AF Cycle Length

  At the start of the procedure from the insertion of the CS catheter to the first ablation

Study Arms (1)

Persistent AF Arm

Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation

Procedure: Cardiac Ablation for the treatment of persistent Atrial Fibrillation

Interventions

Cardiac Ablation for the treatment of persistent Atrial Fibrillation PROCEDURE

Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.

Persistent AF Arm

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 already referred to undergo a cardiac ablation as treatment for persistent atrial fibrillation

You may qualify if:

• Patients scheduled for RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
• Male or female ≥ 21 years of age.
• 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.
• Patients who, in the opinion of the investigator, are not candidates for 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 patient'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.
• Patients who are considered part of any vulnerable population.
• Patient is a prisoner.

Sponsors & Collaborators

• CathVision ApS: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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: Clinical Research Manager
• Organization: CathVision ApS

kpf@cathvision.com

0702097102

Study Officials

• Larry Jacob, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

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: June 17, 2022
• First Posted: July 14, 2022
• Study Start: July 28, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2024
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)