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

NCT03831516 | Completed FDA Device

• 1 other identifier: 18-0364
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ventricular Complex; Ventricular Arrythmia

Keywords

Ablation; Ventricular Tachycardia; Mapping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Preferential Electrical Propagation of Ventricular Arrhythmia

  12 month

Study Arms (1)

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

Interventions

Non Invasive Electroanatomical Mapping DIAGNOSTIC_TEST

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.

Non Invasive Electroanatomical Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Study Officials

• Stavros Mountantonakis, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Cardiac Electrophysiology

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 5, 2019
• Study Start: January 4, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)