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出境医 / 临床实验 / A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans

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

Study Description
Brief 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.

Condition or disease Intervention/treatment
Ventricular Arrythmia Infarction, Myocardial Device: CardioZ multifrequency impedance recording system

Detailed 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.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : February 4, 2022
Estimated Study Completion Date : February 25, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
CASE GROUP
patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias
 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.
Other Name: Cardio-Z
Outcome Measures
Primary Outcome Measures :
  1. Comparative detection of infarct scar by voltage mapping [ Time Frame: 3 hours ]
    Voltage will be measured at different sites of the infarct scar and healthy tissue.

  2. Comparative detection of infarct scar by impedance mapping [ Time Frame: 3 hours ]
    myocardial local impedance will be measured at different sites of the infarct scar and healthy tissue.

  3. Comparative detection of infarct scar by gadolinium enhanced MR imaging [ Time Frame: 30 minutes ]
    Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic myocardial infarction undergoing ablation of ventricular arrhythmias.
Criteria

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
Contacts and Locations

Contacts
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Contact: Juan Cinca Cuscullola, Professor +34935537058 jcinca@santpau.cat
Contact: Laia Angli +34935537058 langli@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08026
Contact: Laia Angli    +34935537058    langli@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Universitat Politècnica de Catalunya
Tracking Information
First Submitted Date June 17, 2019
First Posted Date June 27, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date March 19, 2019
Estimated Primary Completion Date February 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2019)
  • Comparative detection of infarct scar by voltage mapping [ Time Frame: 3 hours ]
    Voltage will be measured at different sites of the infarct scar and healthy tissue.
  • Comparative detection of infarct scar by impedance mapping [ Time Frame: 3 hours ]
    myocardial local impedance will be measured at different sites of the infarct scar and healthy tissue.
  • Comparative detection of infarct scar by gadolinium enhanced MR imaging [ Time Frame: 30 minutes ]
    Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans
Official Title A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic myocardial infarction undergoing ablation of ventricular arrhythmias.
Condition
  • Ventricular Arrythmia
  • Infarction, Myocardial
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.
Other Name: Cardio-Z
Study Groups/Cohorts CASE GROUP
patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias
Intervention: Device: CardioZ multifrequency impedance recording system
Publications *
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2019) 		25
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 25, 2022
Estimated Primary Completion Date February 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Juan Cinca Cuscullola, Professor +34935537058 jcinca@santpau.cat
Contact: Laia Angli +34935537058 langli@santpau.cat
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000412
Other Study ID Numbers IIBSP-IMS-2015-90
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators Universitat Politècnica de Catalunya
Investigators Not Provided
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date June 2019

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