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

• Conditions: Infarction, Myocardial; Ventricular Arrythmia
• Interventions: Device: CardioZ multifrequency impedance recording system

• Registration Number: NCT04000412
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study Start: 2019-03-19
• Status Verified: 2019-06
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Study First Posted: 2019-06-27
• Last Update Posted: 2019-06-27
• Primary Completion: 2022-02-04
• Study Completion: 2022-02-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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)
• pregnacy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CASE GROUP	CardioZ multifrequency impedance recording system	patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias

Primary Outcome Measures

Name	Time	Method
Comparative detection of infarct scar by impedance mapping	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	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	3 hours	Voltage will be measured at different sites of the infarct scar and healthy tissue.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain