Non-Invasive 3D Mapping for Identifying Origin and Preferential Propagation of Ventricular Arrhythmias
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10075
- Lenox Hill Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Predicting Origin
Time Frame: 12 month
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Measure the diagnostic sensitivity and specificity of non-invasive mapping system in predicting origin of spontaneous ventricular arrhythmias in patients undergoing EPS
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12 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preferential Electrical Propagation of Ventricular Arrhythmia
Time Frame: 12 month
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Identify and describe the presence of preferential electrical propagation of ventricular arrhythmias in patients undergoing EPS.
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12 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stavros Mountantonakis, MD, Northwell Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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