I35.0
Conditions
Interventions
Group 1: Patients with high-grade aortic valve stenosis who receive a regular TAVR
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All adult patients who have received or will receive a transcatheter aortic valve implantation (TAVI) at the University Heart Centre Freiburg - Bad Krozingen or who will receive screening for this purpose will be included. Patients participating in the prospective long-term follow-up require prior written information and consent.
Exclusion criteria
Exclusion criteria: Apart from the patient's refusal to participate, there are no direct exclusion criteria, as this is only a collection of data from an intervention that is being carried out anyway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Primary hospitalisation or TAVI procedure - Success of the TAVI procedure - Post-interventional function of the aortic valve prosthesis - Frequency of periinterventional complications - Long-term assessment of implantation success - Function of the aortic valve prosthesis during follow-up - Post-interventional complications after TAVI procedure - Mortality after TAVI procedure during follow-up - Health-related quality of life (HRQL) - NYHA score - Canadian Cardiovascular Society (CCS) Angina Grade - EuroQoL 5D (EQ-5D-5L) - Toronto Aortic Stenosis Quality of Life questionnaire (TASQ) >> Endpoints for long-term follow-up are collected after 6 months and after 1, 2, 3, 4 and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| o Investigation of factors influencing periprocedural complications, post-interventional function of the aortic valve prosthesis and the success of the TAVI procedure. o Demographic factors o Symptoms of aortic valve stenosis o Pre- and periinterventional parameters: Laboratory, ECG, echocardiography, computed tomography, MRI, coronary angiography. o Procedural characteristics of the TAVI procedure o Investigation of factors influencing the function of the aortic valve prosthesis in the course, post-interventional complications after TAVI procedure, mortality in the course after TAVI procedure, health-related quality of life (HRQL) o Demographic factors o Symptomatology of aortic valve stenosis o Pre- and periinterventional parameters: Laboratory, ECG, echocardiography, computed tomography, MRI, coronary angiography. o Procedural characteristics of the TAVI procedure | — |
Countries
Germany
Contacts
Public ContactConstantin von zur Mühlen
Universitätsklinikum Freiburg
Outcome results
None listed