An Evaluation of the Safety and Performance of the CathVision ECGenius® System.

NCT05301803 | Completed Results

• 1 other identifier: CP-00003-A
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

Conditions

Cardiac Arrhythmia

Keywords

electrophysiology; atrial fibrillation; cardiac ablation

Outcome Measures

Primary Outcomes (2)

• Baseline Noise Comparison

  Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV

  EP and ablation procedures can take up to six hours

• Freedom From Major Adverse Events, Evaluated at Hospital Discharge

  Freedom from major adverse events, evaluated at hospital discharge Adverse events were categorized as one of: An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device. A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE. An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

  From EP procedure to discharge is usually one day.

Interventions

Electrophysiology procedure DEVICE

Electrophysiology testing and cardiac ablation of arrhythmia

Eligibility Criteria

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

Study Population

patients indicated for EP study or cardiac ablation.

You may qualify if:

• Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
• At least 18 years of age.
• Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

You may not qualify if:

• Patient inability to understand or refusal to sign informed consent.
• Patient is a prisoner or under incarceration
• Patients who in the opinion of the physician are not candidates for this study.

Sponsors & Collaborators

• CathVision ApS: lead
• Medicept Inc.: collaborator

Study Sites (1)

The University of vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Manager
• Organization: CathVision ApS

kpf@cathvision.com

+4531324745

Study Officials

• Nathaniel C Thompson, MD PhD

  The University of Vermont Medical Center

  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: March 21, 2022
• First Posted: March 31, 2022
• Study Start: March 29, 2022
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)