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

NCT ID: NCT05159180

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-13

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation and Flutter Atrial Arrhythmia Atrial Fibrillation Recurrent

Keywords

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impedance spectroscopy phase angle impedance magnitude Electroanatomical mapping

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with atrial arrhythmias undergoing catheter ablation of these

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.

cardioz mapping

Intervention Type DEVICE

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

Interventions

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cardioz mapping

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

Intervention Type DEVICE

Eligibility Criteria

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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.

* Subjects who present any type of complication during the procedure.
* Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jose M Guerra, MD, PhD

Role: CONTACT

Phone: +34935537058

Email: [email protected]

Gerard Amorós, MSc, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Laia Angli

Role: primary

References

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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.

Reference Type RESULT
PMID: 27630580 (View on PubMed)

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.

Reference Type RESULT
PMID: 29197656 (View on PubMed)

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.

Reference Type RESULT
PMID: 26608340 (View on PubMed)

Amoros-Figueras G, Moreno-Weidmann Z, Mendez-Zurita F, Soriano-Amores M, Bragos R, Rosell-Ferrer J, Guerra JM. Local multifrequency impedance changes after radiofrequency ablation in human atria: potential use for tissue characterization. Front Cardiovasc Med. 2025 Oct 7;12:1668533. doi: 10.3389/fcvm.2025.1668533. eCollection 2025.

Reference Type DERIVED
PMID: 41126919 (View on PubMed)

Other Identifiers

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IIBSP-IMS-2021-74

Identifier Type: -

Identifier Source: org_study_id