Clinical trial NCT05159180: Development of a New Impedance Mapping System for Ablation of Atrial Arrhythmias in Patients
Official title: Desarrollo de un Nuevo Sistema de Mapeo de Impedancia Para la ablación de Las Arritmias Auriculares en Pacientes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation and Flutter
Atrial Arrhythmia
Atrial Fibrillation Recurrent
Keywords: impedance spectroscopy
phase angle
impedance magnitude
Electroanatomical mapping
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial arrhythmias undergoing catheter ablation

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative detection of atrial scar by voltage mapping
timeFrame: 30 minutes
measure: Comparative detection of atrial scar by impedance mapping
timeFrame: 30 minutes
measure: Comparative detection of atrial scar by gadolinium enhanced MR imaging
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Amoros-Figueras G, Jorge E, Garcia-Sanchez T, Bragos 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.2016.00389. eCollection 2016.
citation: Amoros-Figueras G, Jorge E, Alonso-Martin C, Traver D, Ballesta M, Bragos 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 Apr;15(4):589-596. doi: 10.1016/j.hrthm.2017.11.031. Epub 2017 Dec 27.
citation: Jorge E, Amoros-Figueras G, Garcia-Sanchez T, Bragos 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 Feb 1;310(3):H436-43. doi: 10.1152/ajpheart.00754.2015. Epub 2015 Nov 25.