Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
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Trial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT05672823
- Record updated
- 12 February 2024
- Original description
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.Read full original descriptionShow less
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: Patients must be > 18 years old; Written informed consent is obtained from all patients; Planned for transfemoral TAVI procedure.
Exclusion: 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.