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

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ClinicalTrials.gov Identifier: NCT03667248
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis 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)

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 Design
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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

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Groups and Cohorts
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Intervention Details:
  • 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)

Outcome Measures
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Primary Outcome Measures :
  1. accuracy of aortic valve sizing by preoperative CT scan of the heart [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with implantation of a Sorin Perceval ® sutureless valve at University Hospital Basel/ Switzerland
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667248


Locations
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Switzerland
Herzchirurgie University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Oliver Reuthebuch, PD Dr. med University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03667248    
Other Study ID Numbers: 2018- 00495; CH18Reuthebuch
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
PERCEVAL® sutureless aortic valve prosthesis
aortic valve stenosis
aortic valve replacement
preoperative CT scan of the heart
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction