Vektor vMap™ Clinical Validation Study

Completed

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

• Registration Number: NCT04559061
• Lead Sponsor: Vektor Medical

Brief 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™).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Study Start: 2020-12-01
• Status Verified: 2021-04
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (4)

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

University of California San Diego Health; 🇺🇸 La Jolla, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, California, United States

Sutter Health; 🇺🇸 San Francisco, California, United States