CompletedNot Applicable

Vektor vMap™ Clinical Validation Study

United States225 participantsStarted 2020-12-01

Plain-language 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™).

Who can participate

Age range22 Years – 100 Years

SexALL

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Inclusion criteria

✓. Patient has one of the following clinical arrhythmia/pacing types:
✓. 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.

What they're measuring

Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.

Timeframe: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.

Trial details

NCT IDNCT04559061

SponsorVektor Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04-06

View on ClinicalTrials.gov More Cardiac Arrhythmia trials