NCT05836311

Single Perclose Escalation Technique for Vascular Closure in TAVR

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

Detailed description

Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the double "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath. The use of Femoseal in mild bleedings, and a second Perclose Proglide for moderate to severe bleedings. Compare this SPET technique with double Preclose technique, with two historical cohorts of patients. One cohort of patients with SPET technique since started this technique, and a second cohort with double perclose technique prior to starting SPET technique.

Conditions

• Aortic Valve Stenosis
• Structural Valve Deterioration
• Structural Valve Degeneration

Interventions

Type	Name	Description
DEVICE	One Perclose Proglide Suture	One Perclose Proglide Suture
DEVICE	Two Perclose Proglide Suture	One Perclose Proglide Suture

Timeline

• Start date: 2023-07-19
• Primary completion: 2025-02-19
• Completion: 2025-02-19
• First posted: 2023-05-01
• Last updated: 2023-05-03

Locations

1 site across 1 country: Spain