Vektor vMap™ Clinical Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-04-06

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™).

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Detailed Description

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Cardiac ablation procedure

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No