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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04000412
Other study ID # IIBSP-IMS-2015-90
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 19, 2019
Est. completion date February 25, 2022

Study information

Verified date June 2019
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Juan Cinca Cuscullola, Professor
Phone +34935537058
Email jcinca@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date February 25, 2022
Est. primary completion date February 4, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Universitat Politècnica de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Amorós-Figueras G, Jorge E, Alonso-Martin C, Traver D, Ballesta M, Bragós 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. — View Citation

Amorós-Figueras G, Jorge E, García-Sánchez T, Bragós 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. — View Citation

Jorge E, Amorós-Figueras G, García-Sánchez T, Bragós 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparative detection of infarct scar by voltage mapping Voltage will be measured at different sites of the infarct scar and healthy tissue. 3 hours
Primary Comparative detection of infarct scar by impedance mapping myocardial local impedance will be measured at different sites of the infarct scar and healthy tissue. 3 hours
Primary Comparative detection of infarct scar by gadolinium enhanced MR imaging Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue. 30 minutes
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