Brief Title
German TAVI-Register
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 Description
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.
Study Type
Observational
Primary Outcome
All cause mortality
Secondary Outcome
Short- and long-term results of the documented therapies
Condition
Aortic Valve Stenosis
Study Arms / Comparison Groups
Aortic valve procedures
Description: percutaneous transfemoral aortic valve implantation percutaneous transapical aortic valve implantation percutaneous transaortic aortic valve implantation aortic valve valvuloplasty surgical aortic valve replacement conservative treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
3000
Start Date
January 2009
Completion Date
December 2016
Primary Completion Date
November 2011
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Jochen Senges, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02815514
Organization ID
TAVI
Responsible Party
Sponsor
Study Sponsor
Stiftung Institut fuer Herzinfarktforschung
Study Sponsor
Jochen Senges, MD, Principal Investigator, Stiftung Insitut fuer Herzinfarktforschung
Verification Date
June 2016