Aortic Valve Insufficiency, Aortic Valve Stenosis
Conditions
Keywords
aortic valve stenosis, aortic valve insufficiency, transapical aortic valve implantation, aortic valve replacement, percutaneous aortic valve replacement, aortic valve valvuloplasty
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.
Interventions
None listed
Sponsors
Stiftung Institut fuer Herzinfarktforschung
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Details on operational risk | 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 | 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 | 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. |
| Short- and long-term results of the documented therapies | 5 years | Documentation of procedural results and clinical short-and long-term results of the documented therapies |
| Serious long-term complications | 5 years | Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis and reinterventions |
| Quality of life | 5 years | — |
| Drug treatment | 5 years | — |
| Details of hospital stay | 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. |
Countries
Germany
Outcome results
None listed