Trial document




drksid header

  DRKS00017088

Trial Description

start of 1:1-Block title

Title

Identifikation of arrhythmogenic Substrate using echocardiography and MRI

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Fibrotic remodeling processes can result in the formation of relevant scar, which in turn may constitute the substrate of arrhythmias. This fibrotic substrate is a common target for ablation therapies, serves as an a priori predictor of therapeutic success and is used for risk stratification regarding life threatening ventricular tachycardias. Until now, the identification and quantification of the fibrotic substrate is only part of the clinical work up during catheter ablation procedures (3D-substrate- or voltage-mapping). As this is a highly invasive procedure, a prior identification of the relevant substrate by non-invasive methods would be desirable. Here we will test the applicability of echocardiography in this respect, using invasive substrate mapping and Late-Gadolinium-Enhancement MRI as a reference.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Myocardial fibrotic remodeling processes and the resulting scar constitute and important arrhythmogenic substrate. Until now, substrate identification as a clinical standard is only accomplished by electroanatomical Mapping (3D-Substrate Mapping) in the course of catheter ablation procedures. As this is a highly invasive procedure, a prior identification of the relevant substrate by non-invasive methods would be desirable. Here we will test the applicability of echocardiography in this respect, using invasive substrate mapping and Late-Gadolinium-Enhancement MRI as a reference.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017088
  •   2019/05/08
  •   [---]*
  •   yes
  •   Approved
  •   EA1/252/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
  •   I47 -  Paroxysmal tachycardia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   In patients in whom invasive electroanatomical substrate mapping and catheter ablation is performed (based on a clinical indication), additional non-invasive methods for identification of arrhythmogenic substrate will be applied: a) periprocedural LGE-MR (Late Gadolinium Enhancement) incl. T1 mapping, b) periprocedural echocardiography incl. 2D-strain. The aim is to validate the non-invasive methods using invasive electroanatomical mapping as a reference.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Agreement of Areas of arrhythmogenic substrate as determined by electroanatomical substrate mapping (reference) vs. periprocedural LGE-MRI.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Agreement regarding identification of atrial scar (incl. localisation) between periprocedural 2D-strain echocardiography, periprocedural LGE-MRI and invasive electroanatomical mapping.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/05/12
  •   120
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All patients in which a left atrial of ventricular electroanatomical substrate mapping is performed based on a clinical indication.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Pregnancy; Gadolinium-MRI will not be performed if: GFR < 45 ml/min/1.73 m2; intolerance or allergy against Gadolinium contrast agents; application of Gadolinium contrast agents in the preceding 6 months; denial of the Patient; Echo contrast Agent will not be applied if: intolerance or allergy against Gadolinium contrast agents; denial of the Patient



end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Martin Luther-Krankenhaus Berlin, Kardiologie
    • Mr.  Dr. med.  Ivan  Diaz Ramirez 
    • Caspar-Theyß-Straße 27-31
    • 14193  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Charité - Universitätsmedizin Berlin, Klinik für Kardiologie und Angiologie, Charité Campus Mitte
    • Mr.  Dr. med.  Till  Althoff 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité - Universitätsmedizin Berlin, Klinik für Kardiologie und Angiologie, Charité Campus Mitte
    • Mr.  Dr. med.  Till  Althoff 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.