Development of a New Impedance Mapping System for Ablation of Atrial Arrhythmias in Patients

December 17, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Desarrollo de un Nuevo Sistema de Mapeo de Impedancia Para la ablación de Las Arritmias Auriculares en Pacientes

Precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. Voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave front and is limited by the patient-specific thresholds. Mapping of local myocardial electrical impedance may overcome these limitations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

15

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

Study Contact Backup

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial arrhythmias undergoing catheter ablation

Description

Inclusion Criteria:

  • Age between 18 and 85 years.
  • That they understand and sign the informed consent.
  • That they do not present any contraindication.- Pass the exploration and tests prior to bioimpedance measurements.

Exclusion Criteria:

  • Age outside the range described in the inclusion criteria.
  • Subjects who present any type of complication during the procedure.
  • Pregnancy.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with atrial arrhythmias undergoing catheter ablation of these
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.
Device: cardioz mapping
Patients will be submitted to mapping of both voltage and tissue impedance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative detection of atrial scar by voltage mapping
Time Frame: 30 minutes
Voltage will be measured at different sites of the atrial scar and healthy tissue.
30 minutes
Comparative detection of atrial scar by impedance mapping
Time Frame: 30 minutes
Myocardial local impedance spectroscopy will be measured at different sites of the atrial scar and healthy tissue.
30 minutes
Comparative detection of atrial 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

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 (Anticipated)

December 13, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-IMS-2021-74

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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