Trial document




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  DRKS00007872

Trial Description

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Title

German David Registry: Outcomes and risk factors of failure after
valve-sparing aortic root replacement

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Trial Acronym

German David Registry

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the proposed study is to identify risk factors of reoperation and heart valve dysfunction after aortic valve repair operations. A prospective multi-center register trial will be performed with five participating centers.

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Brief Summary in Scientific Language

The different variants of the David valve-sparing aortic root replacement
operation are attractive treatment alternatives to prosthetic aortic valve
replacement in selected patients. So far, no multicenter studies on this
subject are available, either combining clinical experience and
retrospectively avaible clinical outcome data from different aortic surgical
centers, nor to prospectively collect clinical and functional outcome data.
The exact mechanisms of functional failure of aortic valve reconstruction,
including progression of residual aortic regurgitation, new onset aortic valve
regurgitation late after the procedure, as well as structural valve deterioration
are unknown. The impact of patient-related variables including connective
tissue syndromes, bicuspid aortic valve, or geometrical aspects of the aortic
root have not been completely understood as of now. In addition the
question of selection of specific reconstructive methods on the aortic root as
well as of other components of the aortic root including valve cusps and
commissures and the influence on functional results have not been studied
in detail. The choice of the surgical strategy and early quality assessment of
the repair on the basis of structural details of the aortic valve are based on
subjective, individual judgement and not on evidence. The impact of a list of
preoperative variables including type of bicuspid aortic valve, aortic root
geometry, cusp prolapse and others is not known. These uncertainties
mandate a first-time multicenter trial to combine the available retrospective
outcome data allowing for robust statistical risk factor analysis. A
prospectively designed, national multicenter trial will in the future help to
identify patient-related, valve-related and surgery-related risk factors of
failure of aortic valve sparing surgery. These data will in the future 1.
improve patient selection, 2. spare costs caused by reoperations, 3. improve
longevity of repair and 4. help to standardize aortic valve-sparing surgery.

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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

  •   DRKS00007872
  •   2015/03/12
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  •   no
  •   Approved
  •   546/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

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

  •   A national multicentre, retrospective, risk factor study is proposed. The study design is nonrandomized
    and
    non-blinded. This retrospective study will serve as a basis for the establishment of a prospective clinical registry.

    The planned retrospective evaluation of follow-up information by combining clinical patient
    databases from five national aortic surgical centers entails the following time-points:

    1. Direct postoperative valvular follow up including details of valvular characteristics directly
    after the reconstructive procedure (transesophageal echocardiogram in the operating room)
    2. Early postoperative clinical follow-up which is usually performed within thirty days after the
    procedure including transthoracic echocardiogram on a regular basis
    3. Mid-term postoperative clinical follow-up which is usually performed up to five years after
    the procedure including patient visit, history and transthoracic echocardiogram
    4. Long-term postoperative clinical follow-up, which is usually performed ten years after the
    procedure including patient visit, history and transthoracic echocardiogram. Endpoints are new onset aortic regurgitation, progression of any residual aortic regurgitation, incidence of high grade aortic regurgitation, as well as replacement of the aortic valve with a prosthesis or repeat aortic valve repair. Tested variables include patient-related, repair-related and valve-related characteristics.
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Characteristics

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

- Reoperation at five and ten years after the procedure
- Aortic valve replacement using a prosthesis five and ten years after the procedure

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Secondary Outcome

Residual aortic valve regurgitation, progression of aortic valve regurgitation, new onset aortic valve regurgitation, incidence of more than mild / severe aortic valve regurgitation. Time points for all mentioned endpoints is at five and ten years after the primary procedure.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  •  
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Recruitment

  •   Planned
  •   2015/06/01
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients who underwent one of the variants of the David valve-sparing aortic root
replacement procedure as a primary procedure (I-V, intention to treat) with or without the
addition of aortic valve cusp and/or commissure repair
- Aortic root aneurysm AND/OR
- Ascending aortic aneurysm OR
- Acute aortic dissection OR
- Bicuspid aortic valve OR
- Tricuspid aortic valve
- Any degree of aortic valve regurgitation
- Syndromic patients including Marfan Syndrome, Loeys-Dietz Syndrome, Ehlers-Danlos
Syndrome OR
- Non-syndromic patients

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Exclusion Criteria

- More than mild aortic valve stenosis
- Aortic valve endocarditis
- Reoperation
- Redo-Operation
- Valve not suitable for valve-sparing operation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Herzzentrum Freiburg Bad Krozingen
    • Mr.  Dr. med.   Fabian  Kari 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Mr.  Dr. med.  Fabian  Kari 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Mr.  Dr. med.  Fabian  Kari 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Herzstiftung e.V.
    • Vogtstraße 50
    • 60322  Frankfurt am Main
    • Germany
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Status

  •   Recruiting planned
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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.