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

June 26, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Cinca Cuscullola, Professor
  • Phone Number: +34935537058
  • Email: jcinca@santpau.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic myocardial infarction undergoing ablation of ventricular arrhythmias.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hours
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.
3 hours
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Universitat Politècnica de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 19, 2019

Primary Completion (ANTICIPATED)

February 4, 2022

Study Completion (ANTICIPATED)

February 25, 2022

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (ACTUAL)

June 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-IMS-2015-90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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