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

Atrial Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159180
• Other study ID #: IIBSP-IMS-2021-74
• Status: Recruiting
• Start date: December 13, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Jose M Guerra, MD, PhD
• Phone: +34935537058
• Email: jguerra[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Atrial Fibrillation Recurrent

Intervention

Device:
• cardioz mapping
Patients will be submitted to mapping of both voltage and tissue impedance.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Amorós-Figueras G, Jorge E, Alonso-Martin C, Traver D, Ballesta M, Bragós R, Rosell-Ferrer J, Cinca J. Endocardial infarct scar recognition by myocardial electrical impedance is not influenced by changes in cardiac activation sequence. Heart Rhythm. 2018 — View Citation

Amorós-Figueras G, Jorge E, García-Sánchez T, Bragós R, Rosell-Ferrer J, Cinca J. Recognition of Fibrotic Infarct Density by the Pattern of Local Systolic-Diastolic Myocardial Electrical Impedance. Front Physiol. 2016 Aug 31;7:389. doi: 10.3389/fphys.2016 — View Citation

Jorge E, Amorós-Figueras G, García-Sánchez T, Bragós R, Rosell-Ferrer J, Cinca J. Early detection of acute transmural myocardial ischemia by the phasic systolic-diastolic changes of local tissue electrical impedance. Am J Physiol Heart Circ Physiol. 2016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative detection of atrial scar by voltage mapping	Voltage will be measured at different sites of the atrial scar and healthy tissue.	30 minutes
Primary	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
Primary	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