Vektor vMap™ Clinical Validation Study

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

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

Intervention / Treatment
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* Device: Cardiac ablation procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac ablation procedure|Retrospective data will be collected from cases where successful ablation was completed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT. |  | Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types. |  | Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria. | 
| Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types. |  | Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria. |