Vektor vMap™ Clinical Validation Study

NCT04559061 | Completed FDA Device

• 1 other identifier: 20-PR-1010
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 4

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™).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Interventions

Cardiac ablation procedure DEVICE

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

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Vektor Medical: lead
• Experien Group: collaborator

Study Sites (4)

Medical University of South Carolina

Charleston, California, 29425, United States

Location

University of California San Diego Health

La Jolla, California, 92093, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Sutter Health

San Francisco, California, 94107, United States

Location

Related Publications (1)

• 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.

  PMID: 36069189 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Fibrillation; Atrial Premature Complexes; Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Tachycardia, Reciprocating

Study Officials

• Chris Villongco, PhD

  Vektor Medical

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: December 1, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (4)