Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007725

Trial Description

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Title

Feasibility Study of the Edwards Self-Expanding Mitral THV System: Edwards Self-Expanding Mitral Transcatheter Heart Valve with Transapical Delivery System and Accessories

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Trial Acronym

Not Applicable

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The Edwards Self-Expanding Mitral THV System is intended for treatment of subjects with clinically significant, symptomatic mitral regurgitation who are at high risk for surgical mitral valve repair or replacement.

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Brief Summary in Scientific Language

This is a multi-center, prospective, feasibility study. 15 subjects will be enrolled in the study. All enrolled study subjects will be assessed for clinical follow-up at the following intervals: 1 month, 3 months, 6 months, 9 months, 1 year and annually for 5 years post implant procedure.

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Organizational Data

  •   DRKS00007725
  •   2015/01/26
  •   [---]*
  •   no
  •   Approved
  •   FF 18/2014, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  •   CIV-14-02-011879 
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Health Condition or Problem studied

  •   Subjects with clinically significant, symptomatic mitral regurgitation requiring either mitral valve repair or replacement who are at high surgical risk as assessed by the Heart Team.
  •   I34.0 -  Mitral (valve) insufficiency
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Interventions/Observational Groups

  •   Edwards Self-Expanding Mitral THV System: Edwards Self-Expanding Mitral Transcatheter Heart Valve with Transapical Delivery System and Accessories
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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

Freedom from death at 30 days from the implant procedure

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Secondary Outcome

Freedom from heart failure hospitalization at 1 year from the implant procedure

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/08/23
  •   15
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Signed and dated EC approved study consent form prior to study related procedures
2. Sixty years of age or older
3. Clinically significant, symptomatic mitral regurgitation
4. Willing to attend study follow-up assessments for up to 5 years

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Exclusion Criteria

Mitral valve anatomy not suitable for the study device

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Addresses

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    • Edwards Lifesciences
    • 92614  Irvine
    • United States
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Edwards Lifesciences
    • Ms.  Jill  Trekell 
    • One Edwards Way
    • 92614  Irvine
    • United States
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    • Edwards Lifesciences
    • Ms.  Jill  Trekell 
    • One Edwards Way
    • 92614  Irvine
    • United States
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Sources of Monetary or Material Support

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    • Edwards Lifesciences
    • 92614  Irvine
    • United States
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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.