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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation and Flutter, Atrial Arrhythmia, Atrial Fibrillation Recurrent

Intervention / Treatment
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* Device: cardioz mapping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with atrial arrhythmias undergoing catheter ablation of these<br>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<br>* Patients will be submitted to mapping of both voltage and tissue impedance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative detection of atrial scar by voltage mapping | Voltage will be measured at different sites of the atrial scar and healthy tissue. | 30 minutes | 
| Comparative detection of atrial scar by impedance mapping | 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 | Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impedance spectroscopy, phase angle, impedance magnitude, Electroanatomical mapping