Aortic valve stenosis, peripheral artery disease
Conditions
Interventions
Group 1: Transfemoral transcatheter aortic valve replacement with access vessel stenosis and possible indication for lithotripsy (treatment group)
Group 2: Transfemoral transcatheter aortic valve repl
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Informed consent - = 18 years - Severe aortic valve stenosis - Heart Team recommends TAVI - Usable computed tomography of the access vessels - Puncture of the femoral arteries is technically possible (if transfemoral access is planned)
Exclusion criteria
Exclusion criteria: - Further severe valvular heart diseases that require treatment within <3 months - Surgical aortic valve replacement planned - Pregnancy - Occlusion of the pelvic vessels or stenoses that make intravascular lithotripsy impossible (if transfemoral access is planned)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful transfemoral TAVI after intravascular lithotripsy based on predefined morphological criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.) Safety and effectiveness of intravascular lithotripsy 2.) Analysis of the developed morphological criteria of the iliofemoral arteries 3.) The frequency of use of intravascular lithotripsy in clinical practice 4.) The benefit of intravascular lithotripsy by evaluating clinical peripheral artery disease stage, repeat vascular interventions, NYHA class and "Major Cardiovascular Events" (MACE: death, stroke, myocardial infarction) immediately after TAVI and in a telephone follow-up after 3 months assessed 5.) Safety endpoints: periprocedural death, vascular complications (dissection, perforation, vascular occlusion or stenosis, bleeding), contrast medium volume and radiation dose | — |
Countries
Germany
Contacts
Public ContactConstantin von zur Mühlen
Universitätsklinikum Freiburg
Outcome results
None listed