Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010273

Trial Description

start of 1:1-Block title

Title

Long Term Surveillance of Patients with Right ventricular outflow tract dysfunction treated by surgical conduit implantation versus percutaneous pulmonary valve implantation with Melody Valve

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

Long-term surveillance of patients with a narrowing or the lack of heart valve between the right ventricle and the pulmonary artery

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

Brief Summary in Scientific Language

Long term surveillance of Patients with right ventricular outflow tract dysfunction

Amendement: Subsequent changes; extension and prolongation of patient data collection (formal changes).
Ethics committee aproval 02.04.2019 (229/14S)

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

Organizational Data

  •   DRKS00010273
  •   2016/04/14
  •   [---]*
  •   yes
  •   Approved
  •   229/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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

  •   I37.0 -  Pulmonary valve stenosis
  •   I37.1 -  Pulmonary valve insufficiency
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Follow up of patients with right ventricular outflow tract dysfunction treated by a percutaneuous pulmonary valve implantation with the melody valve.
    be observed by
    Echo data: LVOT gradient and mean peak, tricuspid regurgitation, pulmonary regurgitation, Right ventricular function,
    Xray : stent fractures / embolization,
    spiroergometry: efficiency
    MRT and physical examination
  •   Follow up of patients with right ventricular outflow tract dysfunction treated by a surgical conduit implantationtreated with operative pulmonary valve replacement as Hancock, homograft, Contegra
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group), Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

conduit survival defined as time to explant, re-intervention or re-operation
Observation period at least 2 years

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

Secondary Outcome

death, endocarditis, structural conduit dysfunction
Observation period at least 2 years
The dysfunction is charged by data Echo

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

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

Recruitment

  •   Actual
  •   2014/08/01
  •   400
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

All patients >= 5 years who received either a percutaneous Melody valve
or a biological conduit for RVOT dysfunction at the German Heart Centre Munich since 2006
-Patient informed consent / data release form

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

Exclusion Criteria

Patients < 5 years of age

Previous percutaneous valve implantation

No Patient informed consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsches Herzzentrum München
    • 80636  München
    • 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 scientific-contact
    • Deutsches Herzzentrum München Klinik für Kinderkardiologie und angeborene Herzfehler
    • Mr.  Prof. Dr.  Peter  Ewert 
    • Lazarettstr.36
    • 80636  München
    • 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
    • Deutsches Herzzentrum München Klinik für Kinderkardiologie und angeborene Herzfehler
    • Mr.  PD Dr.  Andreas  Eicken 
    • Lazarettstr.36
    • 80636  München
    • 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
    • Medtronic GmbH
    • Earl-Bakken-Platz
    • 40670  Meerbusch
    • 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 ongoing
  •   [---]*
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.