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Clinical Trials/NCT04000412
NCT04000412
Unknown
Not Applicable

A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country25 target enrollmentMarch 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Arrythmia
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
25
Locations
1
Primary Endpoint
Comparative detection of infarct scar by impedance mapping
Last Updated
6 years ago

Overview

Brief Summary

Precise identification of the infarct scar is essential for successful catheter ablation of ventricular arrhythmias in patients with chronic myocardial infarction. Voltage mapping of endocardial electrograms is currently used to delineate the necrotic scar but this is influenced by the direction of the activation wave front and is not sensitive enough to differentiate distinct degrees of transmural injury in the scar. Mapping of local myocardial electrical impedance may overcome these limitations.

Detailed Description

Clinical series: Patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging. The impedance system is already constructed and certified for clinical research use.

Registry
clinicaltrials.gov
Start Date
March 19, 2019
End Date
February 25, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • More than 18 yearts
  • Chronic myocardial infarction
  • Undergoing ventricular ablation of ventricular arrhythmias

Exclusion Criteria

  • patients with device not suitable for cardiac magnetic ressonance (CMR)

Outcomes

Primary Outcomes

Comparative detection of infarct scar by impedance mapping

Time Frame: 3 hours

myocardial local impedance will be measured at different sites of the infarct scar and healthy tissue.

Comparative detection of infarct scar by gadolinium enhanced MR imaging

Time Frame: 30 minutes

Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue.

Comparative detection of infarct scar by voltage mapping

Time Frame: 3 hours

Voltage will be measured at different sites of the infarct scar and healthy tissue.

Study Sites (1)

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