NCT03667248

Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Detailed description

Patients with severe aortic stenosis undergo aortic valve replacement (AVR). One approach to reduce trauma and operation time is the implantation of a sutureless valve to reduce aortic cross-clamp time due to the missing necessity of suturing the valve. Until now, sizing of the valve was determined intraoperatively using the measuring devices provided by the product manufacturer. Due to the implantation mechanism, the valve has to be collapsed after determination of the size. This is consuming time and can seriously delay the procedure. This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Sorin Perceval ® Sutureless Valve (Sorin Group Italia Srl, 13040 Saluggia, Italy), available in different sizes (S 19-21mm, M 21-23mm, L 23-25mm, XL 25-27mm)	Sizing of the valve by preoperative CT scan of the heart and comparison of this measurement with the standard procedure (Sizing intraoperatively using the measuring devices provided by the product manufacturer)

Timeline

• Start date: 2018-05-02
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2018-09-12
• Last updated: 2023-07-20

Locations

1 site across 1 country: Switzerland