Facilitating TRansfEmorAl TAvi By Lithotripsy rEgistry
Not Applicable
- Conditions
- Aortic valve stenosis, peripheral artery disease
- Registration Number
- DRKS00034681
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 229
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
- 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful transfemoral TAVI after intravascular lithotripsy based on predefined morphological criteria.
- Secondary Outcome Measures
Name Time Method 1.) Safety and effectiveness of intravascular lithotripsy<br>2.) Analysis of the developed morphological criteria of the iliofemoral arteries<br>3.) The frequency of use of intravascular lithotripsy in clinical practice<br>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<br>5.) Safety endpoints: periprocedural death, vascular complications (dissection, perforation, vascular occlusion or stenosis, bleeding), contrast medium volume and radiation dose