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
Radboud University Medical Center·ClinicalTrials.gov·procedureRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
Transcatheter Aortic Valve Implantation (TAVI)
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Radboud University Medical Center
Location
Nijmegen,Amsterdam,Amsterdam,Breda,Eindhoven,Maastricht,Nieuwegein,Zwolle, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Nov 28, 2022
End date
Jan 31, 2025
Enrollment
238 participants
Primary outcome

Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both

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.

ICD-10 classifications
Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05672823
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05672823 through Pure Global AI's free database. This phase not specified trial is sponsored by Radboud University Medical Center and is currently Recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 238 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.