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Completed

NCT Number: NCT04559061

Vektor vMap™ Clinical Validation Study

This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Atrial Premature Complexes Atrioventricular Reentrant Tachycardia Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Atrial Complex Premature Ventricular Complexes Multiple Tachycardia Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Reciprocating Tachycardia, Ventricular Ventricular Arrythmia Ventricular Fibrillation Ventricular Tachycardia

Age range

22 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina, Charleston, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has one of the following clinical arrhythmia/pacing types:
  • Atrial pacing
  • Atrial fibrillation
  • Ventricular pacing
  • Premature ventricular complex
  • Ventricular tachycardia
  • Ventricular fibrillation
  • Focal atrial tachycardia
  • Premature atrial complex
  • Atrioventricular reentrant tachycardia
  • Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
  • Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
  • Patient has undergone a successful ablation procedure.
  • Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
  • Patient was between 22 and 100 years of age at time of EP study and ablation procedure.

Exclusion criteria

Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.

Treatment and study plan

Cardiac ablation procedure

Device

Retrospective data will be collected from cases where successful ablation was completed.

Primary outcomes

  1. Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.

    Time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.

Secondary outcomes

  1. Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.

    Time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.

  2. Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types.

    Time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.

Sponsors and collaborators

Lead sponsor

Vektor Medical

Industry

Collaborators

  • Experien Group

Registry information

Official study title

Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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