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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05159180
Enrollment
15
Registered
2021-12-16
Start date
2021-12-13
Completion date
2022-12-31
Last updated
2021-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Arrhythmia, Atrial Fibrillation and Flutter, Atrial Fibrillation Recurrent

Keywords

impedance spectroscopy, phase angle, impedance magnitude, Electroanatomical mapping

Brief summary

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

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.

Interventions

DEVICEcardioz mapping

Patients will be submitted to mapping of both voltage and tissue impedance.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparative detection of atrial scar by voltage mapping30 minutesVoltage will be measured at different sites of the atrial scar and healthy tissue.
Comparative detection of atrial scar by impedance mapping30 minutesMyocardial local impedance spectroscopy will be measured at different sites of the atrial scar and healthy tissue.
Comparative detection of atrial scar by gadolinium enhanced MR imaging30 minutesIntensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue

Countries

Spain

Contacts

Primary ContactJose M Guerra, MD, PhD
jguerra@santpau.cat+34935537058
Backup ContactGerard Amorós, MSc, PhD
gamorosf@santpau.cat

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026