A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans

NCT ID: NCT04000412

Last Updated: 2019-06-27

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

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-19

Study Completion Date

2022-02-25

Brief Summary

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Precise identification of the infarct scar is essential for successful catheter ablation of ventricular arrhythmias in patients with chronic myocardial infarction. Voltage mapping of endocardial electrograms is currently used to delineate the necrotic scar but this is influenced by the direction of the activation wave front and is not sensitive enough to differentiate distinct degrees of transmural injury in the scar. Mapping of local myocardial electrical impedance may overcome these limitations.

Detailed Description

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Clinical series: Patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging. The impedance system is already constructed and certified for clinical research use.

Conditions

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Ventricular Arrythmia Infarction, Myocardial

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CASE GROUP

patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias

CardioZ multifrequency impedance recording system

Intervention Type DEVICE

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.

Interventions

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CardioZ multifrequency impedance recording system

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.

Intervention Type DEVICE

Other Intervention Names

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Cardio-Z

Eligibility Criteria

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Inclusion Criteria

* More than 18 yearts
* Chronic myocardial infarction
* Undergoing ventricular ablation of ventricular arrhythmias

Exclusion Criteria

* patients with device not suitable for cardiac magnetic ressonance (CMR)
* pregnacy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Politècnica de Catalunya

OTHER

Sponsor Role collaborator

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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Juan Cinca Cuscullola, Professor

Role: CONTACT

+34935537058

Laia Angli

Role: CONTACT

+34935537058

Facility Contacts

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Laia Angli

Role: primary

+34935537058

References

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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 BACKGROUND
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 BACKGROUND
PMID: 26608340 (View on PubMed)

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 BACKGROUND
PMID: 27630580 (View on PubMed)

Other Identifiers

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IIBSP-IMS-2015-90

Identifier Type: -

Identifier Source: org_study_id

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