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

Ventricular Arrythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04000412
• Other study ID #: IIBSP-IMS-2015-90
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Infarction
• Infarction, Myocardial
• Myocardial Infarction
• Ventricular Arrythmia

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