Clinical Trial: German TAVI-Register

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Deutsches TAVI-Register

Brief Summary: The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented.

Detailed Summary:

Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies:

  1. Percutaneous transfemoral aortic valve replacement
  2. Percutaneous aortic valve replacement transapical
  3. Percutaneous aortic valve replacement transaortic
  4. Aortic valve balloon valvuloplasty
  5. Surgical aortic valve replacement

  6. Conservative treatment

    • Documentation of the indications, procedural results and clinical short-and long-term results of the above therapies
    • Documentation of operational risk and quality of life
    • Documentation of the technical implementation of the procedure and success of the intervention and of hospital reinterventions
    • Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status)
    • Documentation of discharge medication and the length of hospital stay
    • Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis, the reintervention and quality of life and of drug therapy within 30 days, 1 year, 3 years and 5 years.

Sponsor: Stiftung Institut fuer Herzinfarktforschung

Current Primary Outcome: All cause mortality [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Short- and long-term results of the documented therapies [ Time Frame: 5 years ]
    Documentation of procedural results and clinical short-and long-term results of the documented therapies
  • Details on operational risk [ Time Frame: up to four weeks ]
    Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.
  • Details of performed procedures [ Time Frame: up to four weeks ]

    Documentation of the indications, the technical implementation of the procedures and success of the intervention and of possible hospital reinterventions.

    Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.

  • Complications during hospital stay [ Time Frame: up to four weeks ]

    Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status).

    Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.

  • Details of hospital stay [ Time Frame: up to four weeks ]

    Documentation of e.g. drug treatment, discharge medication and the length of hospital stay.

    Data are not recorded at a fixed day, but are collected during the initial hospital stay and are submitted when the patient leaves the hospital.

  • Serious long-term complications [ Time Frame: 5 years ]
    Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions
  • Quality of life [ Time Frame: 5 years ]
  • Drug treatment [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: Stiftung Institut fuer Herzinfarktforschung

Dates:
Date Received: March 22, 2011
Date Started: January 2009
Date Completion:
Last Updated: April 12, 2017
Last Verified: June 2016