NCT04000412

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.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

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

Study Start

First participant enrolled

March 19, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

June 17, 2019

Last Update Submit

June 26, 2019

Conditions

Ventricular ArrythmiaInfarction, Myocardial

Keywords

electrical impedancecardiac radiofrequency ablation

Outcome Measures

Primary Outcomes (3)

  • Comparative detection of infarct scar by voltage mapping

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

    3 hours

  • 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

  • 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

Study Arms (1)

CASE GROUP

patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias

Device: CardioZ multifrequency impedance recording system

Interventions

CardioZ multifrequency impedance recording systemDEVICE

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.

Also known as: Cardio-Z
CASE GROUP

Eligibility Criteria

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

Patients with chronic myocardial infarction undergoing ablation of ventricular arrhythmias.

You may qualify if:

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

You may not qualify if:

  • patients with device not suitable for cardiac magnetic ressonance (CMR)
  • pregnacy

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 (3)

  • 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: 29197656BACKGROUND

  • 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: 26608340BACKGROUND

  • 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: 27630580BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Juan Cinca Cuscullola, Professor

CONTACT

+34935537058jcinca@santpau.cat

Laia Angli

CONTACT

+34935537058langli@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

June 17, 2019

First Posted

June 27, 2019

Study Start

March 19, 2019

Primary Completion

February 4, 2022

Study Completion

February 25, 2022

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

ES(1)