Vektor vMap™ Clinical Validation Study

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559061
• Other study ID #: 20-PR-1010
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: April 2021
• Source: Vektor Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Premature Complexes
• Atrioventricular Reentrant Tachycardia
• Cardiac Arrhythmia
• Premature Atrial Complex
• Premature Birth
• Premature Ventricular Complexes Multiple
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Fibrillation
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

Device:
• Cardiac ablation procedure
Retrospective data will be collected from cases where successful ablation was completed.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Vektor Medical	Experien Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.