Trial document





This trial has been registered retrospectively.
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  DRKS00010898

Trial Description

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Title

REACTion on long episodes of atrial tachycardia detected with Lumax DX

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Trial Acronym

REACT DX

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URL of the Trial

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Brief Summary in Lay Language

Within this registry the effect of different therapies for long atrial tachycardia episodes (>6min) will be investigated as there is yet no "gold standard" how to treat these kind of events and what kind of longterm effects result from individually established clinical reactions. Furthermore the ECG history of atrial and ventricular arrhythmias will be documented and analysed. The investigated patient population consists of patients who recieved an implantable cardioverter-defibrillator due to standard indications.

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Brief Summary in Scientific Language

Within this registry the effect of different therapies for long AF/AT episodes (>6min, >190bpm) will be investigated as there is yet no "gold standard" how to treat these kind of events and what kind of longterm effects result from individually established clinical reactions. The investigated patient population consists of standard ICD patients.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010898
  •   2016/08/22
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  •   no
  •   Approved
  •   EA2/117/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
  •   I49.8 -  Other specified cardiac arrhythmias
  •   I47.2 -  Ventricular tachycardia
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Interventions/Observational Groups

  •   Every patient will be implanted with an ICD for primary or secondary prevention. Each patient will get two longterm ECGs. Every patient has to answer EQ-5D-3L questionaire twice.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Main aim of the registry is to investigate the effect of different standard therapies to episodes of atrial tachycardia (duration above 6 minutes at a frequency above 190 beats per minute). Atrial Episodes are continously detecetd and stored by the implanted device.

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Secondary Outcome

- Number of patients with atrial tachycardia (>6min, >190bpm)
- Number of patients with arrhythmic symptoms
- Medical reaction on the first ICD detected and documented event
- Time from occurence to treatment of atrial fibrillation
- Duration and number of atrial and ventricular episodes
- Quality and stability of all relevant system parameters
- History of PP-, PR- and RR-intervals before the onset of atrial and/or ventricular tachycardias

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/11/12
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients with standard ICD indication according to guidelines
- Patient has an implanted Lumax 740 VR-T DX (or successor)
- Usage of Home Monitoring Service Center
- Availability of patient for follow-up visits on a regular basis according to Clinical Investigation Plan
- Patient has signed informed consent form
- Sufficient coverage of mobile phone network

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Exclusion Criteria

- Patients with permanent atrial fibrillation
- Indication for cardiac resynchronization therapy
- Life expectancy of less than six months
- Expected cardiac surgery within 6 months after enrollment
- Age under 18 years
- Enrolled in another cardiac clinical investigation

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Addresses

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    • BIOTRONIK SE & Co. KG
    • 12359  Berlin
    • Germany
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    • SANA Klinikum Lichtenberg
    • Mr.  Dr. med.  Alexander  Schirdewan 
    • Fanningerstraße 32
    • 10365  Berlin
    • Germany
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    • SANA Klinikum Lichtenberg
    • Mr.  Dr. med.  Alexander  Schirdewan 
    • Fanningerstraße 32
    • 10365  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • BIOTRONIK SE & Co. KG
    • 12359  Berlin
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/06/30
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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.