Trial document





This trial has been registered retrospectively.
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  DRKS00011798

Trial Description

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Title

Follow-up study to evaluate the impact of atrial fibrillation on mortality and the occurrence of complications in patients with transcatheter aortic valve implantation

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Trial Acronym

TAVI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Both the aortic valve stenosis and the atrial fibrillation (AFIB) occur particularly frequently in older multimorbid patients. For the treatment of the aortic valve stenosis, TAVI has established itself for these patients worldwide in recent years. However, if a patient is affected by both diseases, there is as yet no treatment recommendation for optimal postprocedural anticoagulant therapy. In the course of increasing TAVI procedures, the treatment of patients with AFIB represents a special requirement in everyday clinical practice. The main goal of this retrospective study was the influence of the AFIB on the mortality and the occurrence of bleeding, vascular and cerebrovascular complications after TAVI to investigate. Based on this, the development of a uniform therapeutic treatment strategy is planned.

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Brief Summary in Scientific Language

The transcatheter aortic valve implantation (TAVI) has established itself as a therapeutic method of choice for high-risk and inoperable patients with severe symptomatic aortic valve stenosis and is found to be equivalent to conventional aortic valve replacement in patients with intermediate surgical risk. In a high proportion of TAVI patients, AFIB is present, so that oral anticoagulation (OAK) is required post-procedurally in addition to platelet-inhibiting therapy. In this regard, no uniform, evidence-based recommendations exist to date. The aim of this work was to investigate the effects of AFIB on mortality and complications on the basis of the VARC-2 criteria according to TAVI and to evaluate post-procedural coagulation inhibition therapy in patients with AFIB. This study is retrospective data evaluation of patient data collected in the routine.

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Organizational Data

  •   DRKS00011798
  •   2017/03/31
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   keine, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1193-3555 
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Health Condition or Problem studied

  •   Z95.4 -  Presence of other heart-valve replacement
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Interventions/Observational Groups

  •   Patients with AFIB (forcer) plus TAVI

    Patients are examined for the occurrence of bleeding, vascular complications and mortality. Parameters such as blood values and vital signs, ECG and events are collected before implantation and during the course of the course after 30 days, 3, 6, 9 and 12 months. It is a retrospective data evaluation.

    Comparison of the anticoagulant therapy present at the beginning of the study
    1. ASS 100 + Fallitrom or
    2. ASS 100 + NOAK or
    5. ASS 100 + Plavix or
    3. ASS 100 + Plavix 75 + Fallitrom or
    4. Plavix + NOAK
  •   Patients with sinus rythm (SR) plus TAVI

    Patients are examined for the occurrence of bleeding, vascular complications and mortality. Parameters such as blood values and vital signs, ECG and events are collected before implantation and during the course of the course after 30 days, 3, 6, 9 and 12 months. It is a retrospective data evaluation.

    At the beginning of the study, anticoagulant therapy only with ASS 100 + Plavix 75
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Complications of the blood, cerebrovascular events, vascular complications and mortality are retrospectively recorded and evaluated using the VARC criteria.

Events are collected before implantation and during the course of the course after 30 days, 3, 6, 9 and 12 months.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/05/01
  •   350
  •   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

Patients with successful TAVI implantation.

Data from patients treated retrospectively from 2010-2017 are evaluated.

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Exclusion Criteria

Not successful TAVI implantation or conversion to heart surgery.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Kardiologie und Angiologie
    • Mr.  Prof. Dr. med.  Rüdiger-C.  Braun-Dullaeus 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitästklinik für Kardiologie und Angiologie
    • Mr.  PD Dr. med.  Jörg  Herold 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Kardiologie und Angiologie
    • Mr.  Prof. Dr. med  Rüdiger-C.  Braun-Dulleaus 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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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.