Clinical trial NCT04559061: Vektor vMap™ Clinical Validation Study
Official title: Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Atrial Fibrillation
Ventricular Arrythmia
Premature Ventricular Complexes Multiple
Ventricular Tachycardia
Ventricular Fibrillation
Premature Atrial Complex
Atrioventricular Reentrant Tachycardia
Lead sponsor: Vektor Medical
Sponsor class: INDUSTRY
Collaborators: name: Experien Group
First posted: 2020-09-22
Enrollment: 225
Sex: ALL
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.

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™).


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.
timeFrame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
Secondary outcomes:
measure: Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.
timeFrame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
measure: Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types.
timeFrame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: California
city: La Jolla
country: United States
facility: University of California San Diego Health
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: San Francisco
country: United States
facility: Sutter Health
state: California
Study officials:
affiliation: Vektor Medical
name: Chris Villongco, PhD
role: STUDY_CHAIR
References:
citation: 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.