Aortic Valve Stenosis
Conditions
Brief summary
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.
Detailed description
The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.
Interventions
DEVICEaortic valve prostheses
balloon-expandable and self-expandable aortic valve prostheses
Sponsors
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Aortic stenosis * Intermediate-to-high risk for surgery * Heart team decision
Exclusion criteria
* Contraindication to transfemoral TAVI procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of post-TAVI aortic regurgitation | 30 days | echocardiographicall and angiographycally determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of bleeding complications | 30 days | defined according to BARC and VARC-2 classification |
| mortality | 30 days | all-cause and cardio/cerebrovascular death |
| mortality rate | 2-years | all-cause and cardio/cerebrovascular death |
| incidence of cerebrovascular events | 30 days | stroke or TIA |
| incidence of new pacemaker implantation | 30-day | pacemaker after TAVI |
Other
| Measure | Time frame | Description |
|---|---|---|
| incidence of vascular complications | 30 days | defined according to VARC-2 classification |
| incidence of re-hospitalisation | 2-year | new unplanned hospital stay due to cardiovascular und cerebrovascular reasons |
Countries
Germany
Outcome results
None listed