I35.0
Conditions
Interventions
Group 1: Radial approach for secondary arterial access
Group 2: Transfemoral approach for secondary arterial access
Sponsors
Universitäts-Herzzentrum Freiburg Bad Krozingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: I1. Patients with aortic valve stenosis scheduled for transfemoral TAVI I2. Heart team agrees on eligibility for transfemoral TAVI I3. Age > 65 years I4. Written informed consent
Exclusion criteria
Exclusion criteria: E1. Non accessible radial arteries as judged by the TAVI team E2. Non accessible femoral arteries as judged by the TAVI team E3. Hemodynamic instability E4. Cardiogenic shock E5. Currently participating in an investigational drug or another device study.. E6. Lack of capability to give informed consent E7. Patient refuses TAVR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular and bleeding complications according to the VARC-3 criteria related to the secondary vascular access site until day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Until 30 days after index procedure: • VARC-3 technical success • Cardiovascular mortality • Non-cardiovascular mortality • Mortality related to vascular and bleeding complications • Incidence of new neurological events after randomization (TIA/Stroke) • Quality of life assessed by EQ-5D-5L questionnaire • Health economic aspects, i.e. cost-effectiveness until day 30 • Vascular complication as defined by VARC at 30 days • Bleeding complications at 30 days as defined by VARC • Incidence of acute kidney injury as defined by VARC Until 12 months after index procedure: • All-cause mortality • Cardiovascular mortality • Non-cardiovascular mortality | — |
Countries
Germany
Contacts
Public ContactConstantin von zur Mühlen
Universitäts-Herzzentrum Freiburg Bad Krozingen
Outcome results
None listed