Transcatheter Aortic Valve Implantation Registryof the University Heart Centre Freiburg - Bad Krozinge
Recruiting
- Conditions
- I35.0Aortic (valve) stenosis
- Registration Number
- DRKS00029242
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5000
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Primary hospitalisation or TAVI procedure<br>- Success of the TAVI procedure <br>- Post-interventional function of the aortic valve prosthesis<br>- Frequency of periinterventional complications<br>- Long-term assessment of implantation success<br>- Function of the aortic valve prosthesis during follow-up<br>- Post-interventional complications after TAVI procedure<br>- Mortality after TAVI procedure during follow-up <br>- Health-related quality of life (HRQL)<br>- NYHA score <br>- Canadian Cardiovascular Society (CCS) Angina Grade <br>- EuroQoL 5D (EQ-5D-5L) <br>- Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)<br>>> Endpoints for long-term follow-up are collected after 6 months and after 1, 2, 3, 4 and 5 years<br>
- Secondary Outcome Measures
Name Time Method o Investigation of factors influencing periprocedural complications, post-interventional function of the aortic valve prosthesis and the success of the TAVI procedure. <br>o Demographic factors<br>o Symptoms of aortic valve stenosis<br>o Pre- and periinterventional parameters: Laboratory, ECG, echocardiography, computed tomography, MRI, coronary angiography.<br>o Procedural characteristics of the TAVI procedure<br>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)<br>o Demographic factors<br>o Symptomatology of aortic valve stenosis<br>o Pre- and periinterventional parameters: Laboratory, ECG, echocardiography, computed tomography, MRI, coronary angiography.<br>o Procedural characteristics of the TAVI procedure