Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation

Minimally-Invasive Upper Extremity Approach Versus Lower Extremity Approach for Transcatheter Aortic Valve Implantation (TAVI) Accessory Access Sites; A Prospective, Multicenter, Investigator-Initiated, Randomized Clinical Trial

The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve implantation.

The main questions it aims to answer are whether a 'minimally invasive, upper extremity' approach as compared with the standard 'lower extremity' approach:

• Is associated with less clinically relevant access site-related bleeding complications.
• Is associated with a shorter time to mobilization after TAVI.
• Is associated with a shorter duration of hospitalization.
• Has the same early safety outcomes at 30 days post-TAVI.

Participants will be subject to the usual care surrounding a TAVI procedure but will also will be asked to fill out two questionnaires before and after TAVI:

• Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
• Lower Extremity Functional Scale (LEFS)

Researchers will compare the minimally invasive, upper extremity group with the standard lower extremity to see if there are difference regarding the posed questions.

Inclusion Criteria:

• Patients must be > 18 years old.
• Written informed consent is obtained from all patients.
• Planned for transfemoral TAVI procedure.

Exclusion Criteria:

• Inability to obtain informed consent.
• Contra-indication for brachial or femoral vein access (temporary pacemaker access site).
• Contra-indication for radial or femoral artery access (diagnostic access site).
• Use of a cerebral embolic protection device (CEPD) if this requires an additional (arterial) access site.