Vektor vMap™ Clinical Validation Study
Completed
Conditions studied: Cardiac Arrhythmia, Atrial Fibrillation, Ventricular Arrythmia, Premature Ventricular Complexes Multiple, Ventricular Tachycardia, Ventricular Fibrillation, Premature Atrial Complex, Atrioventricular Reentrant Tachycardia
In brief
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™).
Key facts
- Study ID
- NCT04559061
- Run by
- Vektor Medical
- People needed
- 225
- Starts
- 2020-12-01
- Expected to finish
- 2021-04-06
- Last updated by the study team
- 2021-04-08
Who can join
Age: 22 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify 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.
Where it is running
- Medical University of South Carolina — Charleston, California, United States
- University of California San Diego Health — La Jolla, California, United States
- VA San Diego Healthcare System — San Diego, California, United States
- Sutter Health — San Francisco, California, United States
Full record on ClinicalTrials.gov
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