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

• Conditions: Atrial Fibrillation and Flutter; Atrial Fibrillation Recurrent; Atrial Arrhythmia
• Interventions: Device: cardioz mapping

• Registration Number: NCT05159180
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study Start: 2021-12-13
• Study First Posted: 2021-12-16
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with atrial arrhythmias undergoing catheter ablation of these	cardioz mapping	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.

Primary Outcome Measures

Name	Time	Method
Comparative detection of atrial scar by voltage mapping	30 minutes	Voltage will be measured at different sites of the atrial scar and healthy tissue.
Comparative detection of atrial scar by impedance mapping	30 minutes	Myocardial 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 imaging	30 minutes	Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain