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

Ventricular Arrythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831516
• Other study ID #: 18-0364
• Status: Completed
• Start date: January 4, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Premature Ventricular Complex
• Ventricular Arrythmia
• Ventricular Premature Complexes

Intervention

Diagnostic Test:
• Non Invasive Electroanatomical Mapping
All patients will undergo non contrast CT chest and be fitted with the Medtronic CardioInsight wearable 252 electrode vest. Non invasive electroanatomical maps of the ventricular arrhythmia will be created. All patients will be then brought to the electrophysiology laboratory and undergo an invasive electrophysiology study and ablation of the ventricular arrhythmia.

Locations

Country	Name	City	State
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicting Origin	Measure the diagnostic sensitivity and specificity of non-invasive mapping system in predicting origin of spontaneous ventricular arrhythmias in patients undergoing EPS	12 month
Secondary	Preferential Electrical Propagation of Ventricular Arrhythmia	Identify and describe the presence of preferential electrical propagation of ventricular arrhythmias in patients undergoing EPS.	12 month