Trial document




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  DRKS00010233

Trial Description

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Title

Multi-Centre Trial to Evaluate the Clinical Performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects

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Trial Acronym

Ceraflex-ASD-Occluder

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Clinical trial in several german hospitals to confirm the efficacy of the Ceraflex-Occluder ("umbrella") for the closure of atrial septal defects.

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Brief Summary in Scientific Language

The Ceraflex ASD occluder is newly introduced to the Western European Market, published data are very limited. The objective is to assess the clinical performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects (ASD II) in a standard of care setting.

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Organizational Data

  •   DRKS00010233
  •   2016/04/11
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  •   yes
  •   Approved
  •   451/15s, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   Q21.1 -  Atrial septal defect
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Interventions/Observational Groups

  •   Monitoring of patients with scheduled transcatheter closure of Secundum Atrial Septal Defects (ASD II) with Ceraflex-ASD-Occluder
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Characteristics

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

Early performance success, defined as the rate of a successful placement of the device and successful closure of the defect without major complication until the day of discharge.

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Secondary Outcome

Late performance success defined as: successful closure of the defect without major complication (surgical reintervention, device embolization, moderate or large residual shunt, new AV block II or III° ) 6 month after the procedure

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/04/26
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Able to fluently speak and understand German language, existent ostium secundum atrial septal defect (ASD II), presence of a hemodynamically significant ASD II (right ventricular volume overload determined by transthoracic echo (TTE)), defect hole(s) to be covered by an available Ceraflex ASD device, sufficient margin to place the device, Informed Consent prior to treatment and willing to return for the post-treatment evaluation at the implanting institution after 6 month

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Exclusion Criteria

presence of multiple defects which cannot adequately covered by implantation of one device, current participation in another ongoing clinical device or drug trial, recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF), active bacterial and/or viral infection, evidence of intra-cardiac thrombi on echocardiography, any existent disorder that, in opinion of the investigator, might interfere with the conduct of the trial

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Addresses

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    • Deutsches Herzzentrum München
    • Lazarettstr. 36
    • 80636  München
    • Germany
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    • Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Angeborene Herzfehler und Pädiatrische Kardiologie, Universitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg, Deutschland
    • Mr.  Dr.  Jochen  Grohmann 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Herzzentrum Leipzig GmbH - Universitätsklinik, Klinik für Kinderkardiologie
    • Mr.  Prof. Dr. med.  Ingo  Dähnert 
    • Strümpellstraße 39
    • 04289  Leipzig
    • Germany
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    • Deutsches Herzzentrum München Klinik für Kinderkardiologie und angeborene Herzfehler
    • Mr.  Prof. Dr.  Peter  Ewert 
    • Lazarettstr. 36
    • 80636  München
    • Germany
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    • Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
    • Mr.  Prof. Dr.  Andreas  Eicken 
    • Lazarettstr. 36
    • 80636  München
    • Germany
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Sources of Monetary or Material Support

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    • Lifetech Scientific (ShenZhen) Co., Ltd
    • Cybio Electronic Building, Langshan 2nd street
    • 518057  Nanshan District, Shenzhen
    • China
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Status

  •   Recruiting complete, follow-up continuing
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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.