Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004869

Trial Description

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Title

Echocardiographic effect, of diverse stimulation sites of a new quadripolar electrode

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The cardiac resynchronisation therapy (CRT) is an important strategy in the therapy of advanced heart failure.
The new quadripolar electrode (St. Jude Medical) allows the programation of ten different stimulation sites.

The goal of the study is to identify possibilities to optimize this device. Therefore patients, who already have a CRT-system implanted, will be examined. Mainly, we will perform an transthoracic echocardiography in all pacing possibilities in order to look, if there are differences in the hearth function.


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Brief Summary in Scientific Language

The cardiac resynchronization therapy (CRT) is an important strategy in the therapy of advanced heart failure. Many clinical trials have proven the efficiency of the CRT to reduce the mortality and morbility. Even though there are many open questions.


The new quadripolar electrode (St. Jude Medical) allows the programation of ten different stimulation sites. With this device, the stimulation is not only possible at the top of the electrode, but also in other different positions. The different stimulation vectors are telemetry via programmable.
The goal of the study is to identify possibilities to optimize this device.
We could already prove, that the choice of the stimulation vector influences the haemodynamic. Aim of this study is to prove, whether this effect can also be seen in the transtoracic echocardiography, in order to optimize the use of the quadripolar electrode.

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Organizational Data

  •   DRKS00004869
  •   2014/04/10
  •   [---]*
  •   yes
  •   Approved
  •   120/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Z45.0 -  Adjustment and management of cardiac pacemaker
  •   heart failure
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Interventions/Observational Groups

  •   Echocardiographic optimization of CRT System ( St. Jude) with quadripolar electrode.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Echokardiographic differences of diverse pacing configurations modes

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/03/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

St.Jude CRT System with quadripolar electrode, Sinusrythm, informed consensus

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Exclusion Criteria

No informed consensus, atrial fibrillation, AV Block III Age< 18

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Herzzentrum Freiburg-Bad Krotzing
    • Mr.  Dott.  Luca  Trolese 
    • Hugstetterstraße 55
    • 79106  Freiburg
    • Germany
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    • Herzzentrum Freiburg- Bad Krotzing
    • Mr.  Dott.  Luca  Trolese 
    • Hugstetterstraße 55
    • 79106  Freiburg
    • Germany
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    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • Herzzentrum Freiburg- Bad Krotzingen
    • Mr.  Dott.  Luca  Trolese 
    • Hugstetterstraße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Herzzentrum Freiburg-Bad Krotzing
    • Mr.  Dott.  Luca  Trolese 
    • Hugstetterstraße 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.