Summary

Eligibility
for people ages 22-100 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Frederick T Han, MD
Photo of Frederick T Han
Frederick T Han

Description

Summary

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™).

Official Title

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

Keywords

Cardiac Arrhythmia Atrial Fibrillation Ventricular Arrythmia Premature Ventricular Complexes Multiple Ventricular Tachycardia Ventricular Fibrillation Premature Atrial Complex Atrioventricular Reentrant Tachycardia Premature Birth Arrhythmias, Cardiac Tachycardia Tachycardia, Ventricular Ventricular Premature Complexes Atrial Premature Complexes Cardiac ablation procedure

Eligibility

You can join if…

Open to people ages 22-100

  1. Patient has one of the following clinical arrhythmia/pacing types:
  2. Atrial pacing
  3. Atrial fibrillation
  4. Ventricular pacing
  5. Premature ventricular complex
  6. Ventricular tachycardia
  7. Ventricular fibrillation
  8. Focal atrial tachycardia
  9. Premature atrial complex
  10. Atrioventricular reentrant tachycardia
  11. 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.
  12. Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
  13. Patient has undergone a successful ablation procedure.
  14. Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
  15. Patient was between 22 and 100 years of age at time of EP study and ablation procedure.

You CAN'T join if...

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.

Locations

  • University of California San Diego Health
    La Jolla California 92093 United States
  • VA San Diego Healthcare System
    San Diego California 92161 United States

Lead Scientist at UCSD

  • Frederick T Han, MD
    Associate Clinical Professor, Medicine. Authored (or co-authored) 45 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Vektor Medical
ID
NCT04559061
Study Type
Observational
Last Updated