Trial document




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  DRKS00007578

Trial Description

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Title

Trifecta™-10 year results - A monocentric observational study to evaluate the long term results after aortic valve replacement with the Trifecta ™-bioprosthetis

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Trial Acronym

Trifecta 5y

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to control patients who have received a trifecta biological prosthesis within the European accreditation study (CS05002TV) over a period of five years at an annual follow-up in the heart Center Leipzig. In this follow-up an echocardiographic examination should occur, to determine the functionality of the Trifecta biological prosthesis. In addition, the clinical symptoms, survival rates, re operations, adverse events, the occurrence of Endokarditiden and strokes will be analysed.

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Brief Summary in Scientific Language

The aim of this study is to control patients who have received a trifecta biological prosthesis within the European accreditation study (CS05002TV) over a period of five years at an annual follow-up in the heart Center Leipzig. In this follow-up an echocardiographic examination should occur, to determine the functionality of the Trifecta biological prosthesis. In addition, the clinical symptoms, survival rates, re operations, adverse events, the occurrence of Endokarditiden and strokes will be analysed.

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Organizational Data

  •   DRKS00007578
  •   2014/12/02
  •   [---]*
  •   yes
  •   Approved
  •   244/14, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1164-8383 
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Health Condition or Problem studied

  •   I35.0 -  Aortic (valve) stenosis
  •   I35.1 -  Aortic (valve) insufficiency
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Interventions/Observational Groups

  •   An annual follow-up should take place over a period of five years. In this follow-up an echocardiographic examination should occur, to determine the functionality of the Trifecta biological prosthesis. In addition, the clinical symptoms, survival rates, re operations, adverse events, the occurrence of endocarditis and strokes will be analysed.
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Characteristics

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

functioning of Trifecta bioprosthesis by annual echocardiographic examination for 5 years

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Secondary Outcome

Analysis of the clinical symptoms, adverse events, survival rates, re operations, occurrence of endocarditis and stroke within 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/12/06
  •   34
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All patients who have received a trifecta biological prosthesis at the heart centre Leipzig during the European pivotal study (CS05002TV) and who have given informed consent for this study.

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Exclusion Criteria

Patients who did not signed the informed consent form.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Herzzentrum Leipzig GmbH - Universitätsklinik für Herzchirurgie
    • Mr.  Prof. Dr. med.  Sven  Lehmann 
    • Strümpellstr. 39
    • 04289  Leipzig
    • Germany
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    • Herzzentrum Leipzig GmbH - Universitätsklinik für Herzchirurgie
    • Mr.  Prof. Dr. med.  Sven  Lehmann 
    • Strümpellstr. 39
    • 04289  Leipzig
    • Germany
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    • Herzzentrum Leipzig GmbH - Universitätsklinik für Herzchirurgie
    • Mr.  Prof. Dr. med.  Sven  Lehmann 
    • Strümpellstr. 39
    • 04289  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • St. Jude Medical GmbH
    • Postfach 5549
    • 65730  Eschborn
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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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.