Aortic Valve StenosisNCT03753126
Stent Geometry in Sutureless Bioprosthetic Valves
A study testing 4-dimensional volume-rendered computed tomography in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Heart Valve Diseases
- What is being tested?
- 4-dimensional volume-rendered computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to Nov 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
- Provide written informed consent
Who cannot join
- •Contraindication for CT with intravenous contrast injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases
- Being tested
- 4-dimensional volume-rendered computed tomography
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-dimensional volume-rendered computed tomographyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT imaging | Other | Not described Receives: Radiation: 4-dimensional volume-rendered computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional expansion of valve prosthesis
Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve
Measured: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Overall expansion of valve prosthesis
Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve
Measured: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Secondary outcomes (1)
Eccentricity of valve prosthesis
Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100
Measured: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startJan 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Magnus Dalén, Karolinska University Hospital
- Investigators
- Magnus Dalén, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753126
- Sponsor's protocol ID
- Perceval Geometry
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
Publications
Themudo R, Kastengren M, Bacsovics Brolin E, Cederlund K, Svensson A, Dalen M. Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves. Heart Vessels. 2020 Jun;35(6):868-875. doi: 10.1007/s00380-020-01553-9. Epub 2020 Jan 16.
PubMed 31950251
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
- ClinicalTrials.gov ID
- NCT03753126
- Acronym / sponsor ID
- Perceval Geometry
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 26 Nov 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.
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT imaging | Other | Radiation: 4-dimensional volume-rendered computed tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
- Provide written informed consent
Key exclusion criteria (1 listed)
- •Contraindication for CT with intravenous contrast injection
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 |
|---|---|---|
| 4-dimensional volume-rendered computed tomography | Radiation | Cardiac CT imaging |
Primary outcome
Regional expansion of valve prosthesis
Time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve
Overall expansion of valve prosthesis
Time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve
1 secondary outcome
Eccentricity of valve prosthesis
Time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
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 28 Nov 2018.
- Derived from this study: PubMed 31950251Themudo R, Kastengren M, Bacsovics Brolin E, Cederlund K, Svensson A, Dalen M. Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves. Heart Vessels. 2020 Jun;35(6):868-875. doi: 10.1007/s00380-020-01553-9. Epub 2020 Jan 16.
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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.
Magnus Dalén, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-dimensional volume-rendered computed tomography in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Karolinska University Hospital at 1 site in Sweden.
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 1 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 28 Nov 2018. 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 Sweden. 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?
Regional expansion of valve prosthesis (time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753126, which also lists 1 linked publication.
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 28 Nov 2018.