Skip to main content
OpenTrials
Completed

NCT Number: NCT02815514

German TAVI-Register

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut fur Herzinfarktforschung Ludwigshafen

Ludwigshafen, RPF, 67063, Germany

About this study

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

  • Percutaneous transfemoral aortic valve replacement
  • Percutaneous aortic valve replacement transapical
  • Percutaneous aortic valve replacement transaortic
  • Aortic valve balloon valvuloplasty
  • Surgical aortic valve replacement
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with aortic stenosis (degree III) who received one of the following therapies:

  • transapical operative aortic valve implantation
  • operative aortic valve implantation
  • percutaneous aortic valve implantation
  • balloon valvuloplasty

Exclusion criteria

  • missing signed informed consent

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: 5 years

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Serious long-term complications

    Time frame: 5 years

    Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions

  7. Quality of life

    Time frame: 5 years

  8. Drug treatment

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Registry information

Official study title

Deutsches TAVI-Register

Acronym: TAVI

Important dates

Study start
2009
Primary completion
2011
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.