Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005294

Trial Description

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Title

ROUTE registry

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Observational registry documenting the use of the Edwards SAPIEN XT transcetheter heart valve delivered via an aortic Access using the Ascendra+ delivery System.

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Brief Summary in Scientific Language

The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing transaortic transcatheter procedure with the commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ System.

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Organizational Data

  •   DRKS00005294
  •   2013/11/07
  •   [---]*
  •   yes
  •   Approved
  •   5846/13, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   U1111-1149-9900 
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Health Condition or Problem studied

  •   10002918 (Aortic valve stenosis)
  •   10050559 (Aortic valve calcification)
  •   I35.0 -  Aortic (valve) stenosis
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Interventions/Observational Groups

  •   All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System.
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Characteristics

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

Overall mortality within 30d after TAVI.

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Secondary Outcome

- TAVI related in-hospital and 30d mortality
- Complication rates as to VARC2 (Valve Academic Research Consortium-2)
- Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI
- Further establish role of CT-technology in patient screening (valve sizing, complication prevention)

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Countries of Recruitment

  •   Germany
  •   Finland
  •   France
  •   Italy
  •   Netherlands
  •   United Kingdom
  •   Poland
  •   Austria
  •   Denmark
  •   Norway
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Locations of Recruitment

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

  •   Actual
  •   2013/03/07
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System
- Compliance with the indications according to the Instructions for Use (Appendix 12.1)
- Written informed consent

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Exclusion Criteria

- Presence of contraindications as to the Instructions for Use
- TAo with concomitant procedure (e.g. Tao + CABG)
- Participation in the SOURCE XT registry
Data collection and follow-up
Patient data are collected at valve implantation

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Addresses

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    • IPPMed GmbH
    • Osterstr. 15
    • 49661  Cloppenburg
    • Germany
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    • IPPMed GmbH
    • Mr.  PD Dr. med.  Peter  Bramlage 
    • Menzelstr. 21
    • 15831  Mahlow
    • Germany
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    • IPPMed GmbH
    • Ms.  Kerstin  Plate 
    • Osterstr. 15
    • 49661   Cloppenburg
    • Germany
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Sources of Monetary or Material Support

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    • IPPMed GmbH
    • Osterstr. 15
    • 49661  Cloppenburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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