NCT05637983

Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: Fondazione Toscana Gabriele Monasterio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system. We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

Detailed description

Transfemoral approach has become the standard route for a transcatheter aortic valve replacement (TAVR) procedure. Despite the technology improvements, vascular complications and access-related bleeding are frequently observed after TAVR and emerge predominantly within 30 days after TAVR. Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)- guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system. We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
PROCEDURE	US-guided femoral puncture vs Fluoroscopy-guided puncture	US-guided femoral puncture and Perclose ProGlide®/Prostyle implantation compared to Fluoroscopy-guided puncture and Perclose ProGlide®/Prostyle in TAVR

Timeline

• Start date: 2022-07-04
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2022-12-06
• Last updated: 2022-12-06

Locations

1 site across 1 country: Italy