Aortic Valve StenosisNCT03667248
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
An observational study of Aortic Valve Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- 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)
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 May 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with implantation of a Sorin Perceval ® sutureless valve at University Hospital Basel/ Switzerland
Who may be able to join
- Implantation of a Sorin Perceval ® sutureless valve
- availability of preoperative CT scan
Who cannot join
- denial of consent
- missing preoperative CT scan
- bad quality of preoperative CT scan
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 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)
- Keywords
- PERCEVAL® sutureless aortic valve prosthesis, aortic valve stenosis, aortic valve replacement, preoperative CT scan of the heart
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Device
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of aortic valve sizing by preoperative CT scan of the heart
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)
Measured: during surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start2 May 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, PD Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667248
- Sponsor's protocol ID
- 2018- 00495; ch18Reuthebuch
- Other IDs
- 2018
- Status last verified
- Jul 2023
- First submitted
- 10 Sep 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03667248
- Acronym / sponsor ID
- 2018- 00495; ch18Reuthebuch
- Conditions
- Aortic Valve Stenosis
- Keywords
- PERCEVAL® sutureless aortic valve prosthesis, aortic valve stenosis, aortic valve replacement, preoperative CT scan of the heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with implantation of a Sorin Perceval ® sutureless valve at University Hospital Basel/ Switzerland
Key inclusion criteria (2 listed)
- Implantation of a Sorin Perceval ® sutureless valve
- availability of preoperative CT scan
Key exclusion criteria (3 listed)
- denial of consent
- missing preoperative CT scan
- bad quality of preoperative CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Reuthebuch, PD Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of aortic valve sizing by preoperative CT scan of the heart (time frame: during surgery procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.