Vektor vMap™ Clinical Validation Study

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

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™).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Arrythmia; Cardiac Arrhythmia; Premature Ventricular Complexes Multiple; Premature Atrial Complex; Atrioventricular Reentrant Tachycardia
• Intervention / Treatment: Device: Cardiac ablation procedure

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • California
    • Charleston, California, United States, 29425
      • Medical University of South Carolina
    • La Jolla, California, United States, 92093
      • University of California San Diego Health
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System
    • San Francisco, California, United States, 94107
      • Sutter Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Vektor Medical
• Collaborators: Experien Group
• Investigators: Study Chair: Chris Villongco, PhD, Vektor Medical

Publications and helpful links

General Publications

• Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Tachycardia, Reciprocating; Atrial Fibrillation; Premature Birth; Arrhythmias, Cardiac; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes; Atrial Premature Complexes; Tachycardia, Atrioventricular Nodal Reentry
• Other Study ID Numbers: 20-PR-1010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No