Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009223

Trial Description

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Title

Testing of defibrillation during aggregate change of ICD -
additional safety and efficacy benefits or already obsolete?

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Trial Acronym

DIASE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

An implanted defibrillator protect patients from sudden cardiac death and rapid arrhythmia. Distinction is made between a primary indication, in which patients structural heart disease, such as having an ischemic (reduced blood supply of the organ) or dilated cardiomyopathy (enlargement of the heart muscle), and a secondary indication of a state to survive sudden cardiac death in eg Fibrillation, distinguished. Exhausted the battery power of an implanted defibrillator, an aggregate change must be done in order to continue to ensure a safe therapy for the patient. In that aggregate change for checking the functionality of the newly implanted device and the correct probe location be intraoperatively performed functional tests. Here ventricular fibrillation or rapid heart rhythm disorder is triggered and checks to see if the defibrillator detects this properly and with an appropriate therapy delivery, a defibrillation shock, reacts. This study will investigate, in how many and which patients with an implanted defibrillator as part of a conducted aggregate change an intraoperative defibrillation testing has been applied and whether it was successful or ineffective. There are elicited causes and reasons for unsuccessful tests and the resultant intraoperative procedure. It is questioned whether routine tests are required for assembly of an implanted defibrillator change and whether those should be carried out in future only in specific patient groups. Furthermore, investigating the safety and tolerability of intraoperative Defibrillationstestungen and related complications.

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Brief Summary in Scientific Language

In this study, a cohort of 252 patients with an ICD (Implanted Cardioverter Defibrillator)-aggregate change and a possible revision probe or an ICD upgrade scanned because of battery depletion was retrospectively examined, to evaluate the use of intraoperative defibrallation testing. It is documented whether and which patients received an intraoperative defibrillation testing (DFT) and how those tests have failed. To simulate a ventricular fibrillation or ventricular tachycardia those arrhythmias induced iatrogenic intraoperatively after the aggregate change. The ICD is now to detect in a timely manner the tachycardic arrhythmia as such and this in the context of an adequate therapy delivery, a defibrillation shock, schedule. The aim of this study is to investigate the safety and efficacy of intraoperative conducted defibrillation testing during ICD generator replacement. There are presented and reasons and the intraoperative procedure for unsuccessful defibrillation testing. Furthermore, questioned whether any patient with an ICD should receive a defibrillation unit exchange and which are prediction factors to elicit on ineffective tests.

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Organizational Data

  •   DRKS00009223
  •   2015/08/12
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  •   yes
  •   No approval required according to EC
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Secondary IDs

  •   U1111-1173-1183 
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Health Condition or Problem studied

  •   I42.0 -  Dilated cardiomyopathy
  •   I25.5 -  Ischaemic cardiomyopathy
  •   Z45.01 -  [generalization Z45.0: Adjustment and management of cardiac pacemaker]
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Interventions/Observational Groups

  •   Patients without DFT during ICD aggregate change, ie no implementation according indication grantor or operating cardiologist or cardiac surgeon or patients with iatrogenic not inducible ventricular implementing the DFT
  •   Patients with DFT during ICD aggregate change

    of which:
    2a) successful testing, i.e .:
    A defibrillation was considered effective or successful if the iatrogenic induced tachyarrhythmia or ventricular fibrillation has been detected correctly in a reliable timeframe from ICD system and was successfully terminated in connection with the first shock. Here an initial margin of ≥ 10 Joule in terms should be noted on the maximum energy of the implanted pulse generator.

    2b) ineffective tests, that is,
    they were characterized by a misperception of the induced ventricular tachycardia or ventricular fibrillation, and a lack of or inadequate ICD therapy, a non-terminating and incipient in a reasonable timeframe shock from. Thus, the ICD generator under loss of time had to be reloaded or there was an external defibrillation is used.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Prevalence, incidence and prediction factors for ineffective intraoperative DFT during performed ICD generator change

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Secondary Outcome

Safety and tolerability of conducted DFT during ICD generator change, ICD-related complications, compared shock effectiveness and patient mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/01
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Male, Female
2. age: min. 18 years, max. 90 years
3. Patients with ICD generator change

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Exclusion Criteria

1. Lack of consent / awareness for surgical indications, surgical procedure and - complications and with respect to the Defibrillationstestung at an ICD generator change
2. Rejection of use of defibrillation by a patient
3. Lack of legal protection for underage patients
4. Contraindications to ICD generator replacement: poor general condition and such serious diseases, which do not allow such an intervention
5. Contraindications for intraoperative DFT such as intracardiac thrombi, pericardial effusion, pneumothorax, acute coronary syndrome, stroke
6. pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätklinik für Kardiologie, Angiologie und Pneumologie
    • Mr.  Prof. Dr. med.  Rüdiger Christian  Braun-Dullaeus 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Kardiologie, Angiologie und Pneumologie
    • Mr.  Dr.  Thomas  Rauwolf 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Kardiologie, Angiologie und Pneumologie
    • Mr.  Dr.  Thomas  Rauwolf 
    • Leipziger Str. 44
    • 39112  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Kardiologie, Angiologie und Pneumologie
    • Mr.  Prof. Dr. med.  Rüdiger Christian  Braun-Dullaeus 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/01
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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.