Brief Title
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
Official Title
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
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.
Study Type
Observational
Primary Outcome
accuracy of aortic valve sizing by preoperative CT scan of the heart
Condition
Aortic Valve Stenosis
Intervention
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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
7
Start Date
May 2, 2018
Completion Date
March 31, 2019
Primary Completion Date
March 31, 2019
Eligibility Criteria
Inclusion Criteria: - Implantation of a Sorin Perceval ® sutureless valve - availability of preoperative CT scan Exclusion Criteria: - denial of consent - missing preoperative CT scan - bad quality of preoperative CT scan
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Oliver Reuthebuch, PD Dr. med, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT03667248
Organization ID
2018- 00495; CH18Reuthebuch
Responsible Party
Sponsor
Study Sponsor
University Hospital, Basel, Switzerland
Study Sponsor
Oliver Reuthebuch, PD Dr. med, Principal Investigator, University Hospital, Basel, Switzerland
Verification Date
June 2019