This trial is active, not recruiting.

Conditions aortic valve stenosis, aortic valve insufficiency
Sponsor Stiftung Institut fuer Herzinfarktforschung
Start date January 2009
End date December 2011
Trial size 3000 participants
Trial identifier NCT02815514, TAVI


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
percutaneous transfemoral aortic valve implantation percutaneous transapical aortic valve implantation percutaneous transaortic aortic valve implantation aortic valve valvuloplasty surgical aortic valve replacement conservative treatment

Primary Outcomes

All cause mortality
time frame: 5 years

Secondary Outcomes

Short- and long-term results of the documented therapies
time frame: 5 years
Details on operational risk
time frame: up to four weeks
Details of performed procedures
time frame: up to four weeks
Complications during hospital stay
time frame: up to four weeks
Details of hospital stay
time frame: up to four weeks
Serious long-term complications
time frame: 5 years
Quality of life
time frame: 5 years
Drug treatment
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Deutsches TAVI-Register
Principal investigator Jochen Senges, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stiftung Institut fuer Herzinfarktforschung.