Vektor vMap™ Clinical Validation Study

Vektor Medical

Status: Completed

Conditions: Atrial Fibrillation; Premature Ventricular Complexes Multiple; Ventricular Fibrillation; Ventricular Arrythmia; Cardiac Arrhythmia; Premature Atrial Complex; Atrioventricular Reentrant Tachycardia; Ventricular Tachycardia

Treatments: Device: Cardiac ablation procedure

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04559061

20-PR-1010

Details and patient eligibility

About

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™).

Enrollment: 225 patients

Sex: All

Ages: 22 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. 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.

3. Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.

4. Patient has undergone a successful ablation procedure.

5. Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.

6. 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.