Clinical trial NCT02815514: German TAVI-Register
Official title: Deutsches TAVI-Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Keywords: aortic valve stenosis
aortic valve insufficiency
transapical aortic valve implantation
aortic valve replacement
percutaneous aortic valve replacement
aortic valve valvuloplasty
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with significant aortic valve stenosis, treated with aortic valve procedures.

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.

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

Primary outcomes:
measure: All cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Short- and long-term results of the documented therapies
timeFrame: 5 years
measure: Details on operational risk
timeFrame: up to four weeks
measure: Details of performed procedures
timeFrame: up to four weeks
measure: Complications during hospital stay
timeFrame: up to four weeks
measure: Details of hospital stay
timeFrame: up to four weeks
measure: Serious long-term complications
timeFrame: 5 years
measure: Quality of life
timeFrame: 5 years
measure: Drug treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Institut fur Herzinfarktforschung Ludwigshafen
state: RPF
Study officials:
affiliation: Stiftung Insitut fuer Herzinfarktforschung
name: Jochen Senges, MD
role: PRINCIPAL_INVESTIGATOR
References: