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

F

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

Status

Unknown

Conditions

Atrial Fibrillation and Flutter
Atrial Fibrillation Recurrent
Atrial Arrhythmia

Treatments

Device: cardioz mapping

Study type

Observational

Funder types

Other

Identifiers

NCT05159180
IIBSP-IMS-2021-74

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

patients with atrial arrhythmias undergoing catheter ablation of these
Description:
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.
Treatment:
Device: cardioz mapping

Trial contacts and locations

1

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Central trial contact

Jose M Guerra, MD, PhD; Gerard Amorós, MSc, PhD

Data sourced from clinicaltrials.gov

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