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

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Unknown status
CT.gov ID
NCT04000412
Collaborator
Universitat Politècnica de Catalunya (Other)
25
1
35.3
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CardioZ multifrequency impedance recording system

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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans
Actual Study Start Date :
Mar 19, 2019
Anticipated Primary Completion Date :
Feb 4, 2022
Anticipated Study Completion Date :
Feb 25, 2022

Arms and Interventions

Arm Intervention/Treatment
CASE GROUP

patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias

Device: CardioZ multifrequency impedance recording system
Patients will be submitted to mapping of both voltage and tissue impedance. The accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging.
Other Names:
  • Cardio-Z
  • Outcome Measures

    Primary Outcome Measures

    1. Comparative detection of infarct scar by voltage mapping [3 hours]

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

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08026

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Universitat Politècnica de Catalunya

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT04000412
    Other Study ID Numbers:
    • IIBSP-IMS-2015-90
    First Posted:
    Jun 27, 2019
    Last Update Posted:
    Jun 27, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2019