NCT05159180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

December 3, 2021

Last Update Submit

December 17, 2021

Conditions

Atrial Fibrillation and FlutterAtrial ArrhythmiaAtrial Fibrillation Recurrent

Keywords

impedance spectroscopyphase angleimpedance magnitudeElectroanatomical mapping

Outcome Measures

Primary Outcomes (3)

  • Comparative detection of atrial scar by voltage mapping

    Voltage will be measured at different sites of the atrial scar and healthy tissue.

    30 minutes

  • 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

  • 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

Study Arms (1)

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.

Device: cardioz mapping

Interventions

cardioz mappingDEVICE

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

patients with atrial arrhythmias undergoing catheter ablation of these

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with atrial arrhythmias undergoing catheter ablation

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who present any type of complication during the procedure.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27630580RESULT

  • 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.

    PMID: 29197656RESULT

  • 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.

    PMID: 26608340RESULT

  • 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.

    PMID: 41126919DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jose M Guerra, MD, PhD

CONTACT

+34935537058jguerra@santpau.cat

Gerard Amorós, MSc, PhD

CONTACT

gamorosf@santpau.cat

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 16, 2021

Study Start

December 13, 2021

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

December 20, 2021

Record last verified: 2021-12

Locations

ES(1)