Minimally-invasive upper extremity versus lower extremity for accessory access sites during transcatheter aortic valve implantatio
Completed
- Conditions
- abnormal narrowing of the aortic valveaortic valve stenosis10046973
- Registration Number
- NL-OMON51309
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 238
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is clinically relevant bleeding (BARC type 2, 3 or 5) of<br /><br>the randomized access site (either diagnostic or pacemaker access site, or<br /><br>both).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Time to mobilization after TAVI procedure<br /><br>- Duration of hospitalization<br /><br>- Early safety (at 30 days) as defined by VARC-3 criteria<br /><br><br /><br>Efficacy endpoints:<br /><br>- Frequency rate of cross-over to the non-randomized access site (either<br /><br>diagnostic or pacemaker access site, or both)<br /><br>- Fluoroscop time and skin-to-skin time<br /><br>- Failure of the temporary pacemaker</p><br>