Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT03667248
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Implantation of a Sorin Perceval ® sutureless valve
- availability of preoperative CT scan
- denial of consent
- missing preoperative CT scan
- bad quality of preoperative CT scan
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method accuracy of aortic valve sizing by preoperative CT scan of the heart during surgery procedure accuracy of aortic valve sizing by preoperative CT scan of the heart in comparison with the standard procedure (Sizing intraoperatively using the measuring devices provided by the product manufacturer)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Herzchirurgie University Hospital Basel
🇨🇭Basel, Switzerland