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

Status: Completed
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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™).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Medical University of South Carolina
Charleston
University of California San Diego Health
La Jolla
VA San Diego Healthcare System
San Diego
Sutter Health
San Francisco
Time Frame
Start Date: 2020-12-01
Completion Date: 2021-04-06
Participants
Target number of participants: 225
Sponsors
Collaborators: Experien Group
Leads: Vektor Medical

This content was sourced from clinicaltrials.gov