Non-Invasive 3D Mapping for Identifying Origin and Preferential Propagation of Ventricular Arrhythmias

Completed

• Conditions: Premature Ventricular Complex; Ventricular Arrythmia
• Interventions: Diagnostic Test: Non Invasive Electroanatomical Mapping

• Registration Number: NCT03831516
• Lead Sponsor: Northwell Health

Brief Summary

This study will measure the diagnostic sensitivity and specificity of the Medtronic CardioInsight wearable 252 electrode vest in predicting the chamber of origin of premature ventricular complexes (PVCs) and compare its diagnostic accuracy with the standard 12- lead ECG.

Detailed Description

Until recently, the only non-invasive diagnostic modality to help identify the location of ventricular arrhythmias was the 12 lead ECG. The Medtronic CardioInsight wearable vest is a recently FDA approved diagnostic modality noninvasive, single beat cardiac mapping system that provides 3D electroanatomic maps of the ventricular chambers. CardioInsight projects unipolar signals collected from a 252-electrode vest to cardiac chambers imaged with a non-contrast CT of the chest. The created non-invasive 3D electroanatomical maps can be evaluated by the physicians pre-procedurally but also during the actual electrophysiology study (EPS).

The technology has been approved by FDA for non-invasive mapping of any arrhythmias, however there is little evidence on its value in predicting the origin of ventricular arrhythmias and its proven diagnostic superiority over the standard 12-lead ECG.

With this study the investigators seek to assess the sensitivity and specificity of CardioInsight in predicting the chamber of origin of ventricular arrhythmias and compare its diagnostic accuracy with the standard 12-lead ECG. The study will include thirty patients with ventricular arrhythmias undergoing EPS and ablation. The day of the procedure patients will be fitted with the CardioInsight vest and undergo a non-contrast CT chest. Spontaneous arrhythmias will be recorded and noninvasive 3D maps will be created prior and during the EPS. The non-invasive maps will be used, per operator discretion, in designing mapping and ablative strategies during the EPS. The true origin of the arrhythmia will be determined during the EPS. In addition, the investigators will perform threshold pacing from common site of idiopathic ventricular arrhythmias. The 12-lead ECGs and non-invasive maps will be stored for off line review and analysis.

Non-invasive maps, as well as ECGs of spontaneous arrhythmias and pacemaps will be evaluated off line by 2 electrophysiologists blinded to the results of the EPS. The sensitivity and specificity of the 12 lead ECG, as well as the non-invasive maps, in predicting the site of origin of the ventricular arrhythmias and pacemaps will be calculated and compared.

Study Timeline

• Study Start: 2019-01-04
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with PVCs or VT requiring EPS for:
• Symptomatic arrhythmias
• High PVC burden
• Presence of cardiomyopathy
• Risk stratification to determine which patients to offer ablative vs medical therapy and for ICD implantation if deemed high risk for sudden cardiac death.

Exclusion Criteria

• Patients in acute coronary syndrome
• Patient with congestive heart failure in acute decompensation
• Patients in rapid atrial fibrillation
• Patients requiring persistent ventricular pacing
• Patient who refuse to undergo EPS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Invasive Electroanatomical Mapping	Non Invasive Electroanatomical Mapping	Patients will undergo non invasive electroanatomical mapping (CardioInsight by Medtronic) prior and during an invasive electrophysiology study and ablation of ventricular Arrhythmias.

Primary Outcome Measures

Name	Time	Method
Predicting Origin	12 month	Measure the diagnostic sensitivity and specificity of non-invasive mapping system in predicting origin of spontaneous ventricular arrhythmias in patients undergoing EPS

Secondary Outcome Measures

Name	Time	Method
Preferential Electrical Propagation of Ventricular Arrhythmia	12 month	Identify and describe the presence of preferential electrical propagation of ventricular arrhythmias in patients undergoing EPS.

Trial Locations

Locations (1)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States