NCT05672823

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Aortic Valve Implantation (TAVI)	Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site.

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-01-05
• Last updated: 2024-02-12

Locations

8 sites across 1 country: Netherlands