Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation - Trial NCT05672823

Name: Clinical Trial NCT05672823
Creator: Radboud University Medical Center
Keywords: Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), procedure, clinical trial, Netherlands

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.

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NCT05672823

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Trial Details

ClinicalTrials.gov • NCT05672823

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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

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) stenosis

Aortic (valve) stenosis with insufficiency

Congenital stenosis of aortic valve

Stenosis of aorta

Rheumatic aortic stenosis

Data Source

Registry

ClinicalTrials.gov

Trial ID

NCT05672823

Type

Non-Device Trial