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

• ClinicalTrials.gov Identifier: NCT03831516
• Recruitment Status: Recruiting
• First Posted: February 5, 2019
• Last Update Posted: February 10, 2021
• Sponsor: Northwell Health
• Information provided by (Responsible Party): Stavros Mountantonakis, Northwell Health

Study Description

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.

Condition or disease	Intervention/treatment
Premature Ventricular Complex; Ventricular Arrythmia	Diagnostic Test: Non Invasive Electroanatomical Mapping

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 Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Invasive 3D Mapping for Identifying Origin and Preferential Propagation of Ventricular Arrhythmias
• Actual Study Start Date: January 4, 2019
• Estimated Primary Completion Date: December 30, 2021
• Estimated Study Completion Date: December 30, 2021

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. Predicting Origin [ Time Frame: 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 :

1. Preferential Electrical Propagation of Ventricular Arrhythmia [ Time Frame: 12 month ]
   Identify and describe the presence of preferential electrical propagation of ventricular arrhythmias in patients undergoing EPS.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with ventricular arrhythmias (premature ventricular complexes - PVC or ventricular tachycardias - VT) requiring EPS for risk stratification or ablation.

Criteria

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

Contacts and Locations

Contacts

Contact: Stavros Mountantonakis, MD; 212-434-6500; Smountanto@northwell.edu

Contact: Kristie Coleman; 212-434-3878; kcoleman1@northwell.edu

Locations

United States, New York

Lenox Hill Hospital; Recruiting

New York, New York, United States, 10075

Contact: Kristie Coleman 212-434-3878 kcoleman1@northwell.edu

Principal Investigator: Stavros Mountantonakis, MD

Sub-Investigator: Kabir Bhasin, MD

Sub-Investigator: Nicholas Skipitaris, MD

Sub-Investigator: Neil Bernstein, MD

Sponsors and Collaborators

Northwell Health

Investigators

• Principal Investigator: Stavros Mountantonakis, MD; Northwell Health

More Information

• Responsible Party: Stavros Mountantonakis, Associate Director of Cardiac Electrophysiology, Northwell Health
• ClinicalTrials.gov Identifier: NCT03831516
• Other Study ID Numbers: 18-0364
• First Posted: February 5, 2019
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Stavros Mountantonakis, Northwell Health:

Ablation; Ventricular Tachycardia; Mapping

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Ventricular Premature Complexes; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Cardiac Complexes, Premature; Cardiac Conduction System Disease