NCT05503199

Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation

Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.

Detailed description

Detailed information is provided elsewhere.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).	Combined suture- and plug-based VCD strategy after TF-TAVI.
DEVICE	Combination of two ProGlides or ProStyles (Abbott Vascular).	Pure suture-based VCD strategy after TF-TAVI.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-04-18
• Completion: 2024-04-18
• First posted: 2022-08-16
• Last updated: 2024-04-23

Locations

1 site across 1 country: Germany