abnormal narrowing of the aortic valve aortic valve stenosis
Conditions
Interventions
Eligible patients will be randomized in a 1:1 ratio to either the *minimally-
invasive upper extremity* group (i.e. radial artery for pigtail catheter and
brachial vein for temporary pacemaker when n
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be > 18 years old. 2. Written informed consent is obtained from all patients. 3. Planned for transfemoral TAVI procedure.
Exclusion criteria
Exclusion criteria: 1. Inability to obtain informed consent. 2. Contra-indication for brachial or femoral vein access (temporary pacemaker access site). 3. Contra-indication for radial or femoral artery access (diagnostic access site). 4. Use of cerebral embolic protection device (CEPD) if this requires an additional (arterial) access site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is clinically relevant bleeding (BARC type 2, 3 or 5) of the randomized access site (either diagnostic or pacemaker access site, or both). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Time to mobilization after TAVI procedure - Duration of hospitalization - Early safety (at 30 days) as defined by VARC-3 criteria Efficacy endpoints: - Frequency rate of cross-over to the non-randomized access site (either diagnostic or pacemaker access site, or both) - Fluoroscop time and skin-to-skin time - Failure of the temporary pacemaker | — |
Countries
Netherlands
Outcome results
None listed