Aortic Valve StenosisNCT02671474
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
A study testing 4-dimensional volume-rendered computed tomography in people with Aortic Valve Stenosis and Heart Valve Disease, 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 Disease
- What is being tested?
- 4-dimensional volume-rendered computed tomography
- How many people
- 47 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to May 2016
- 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
- Adult, Older adult
Who may be able to join
- Implanted with a sutureless Perceval (Sorin Group) 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.
Sweden1 site
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Stockholm
About this study
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 leaflet motion. 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 Disease
- 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 tomographyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced aortic valve leaflet motion
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 posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMay 2016
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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671474
- Sponsor's protocol ID
- Perceval thrombosis
- Status last verified
- Jul 2016
- First submitted
- 24 Jan 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
Publications
Dalen M, Sartipy U, Cederlund K, Franco-Cereceda A, Svensson A, Themudo R, Svenarud P, Bacsovics Brolin E. Hypo-Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves. J Am Heart Assoc. 2017 Aug 21;6(8):e005251. doi: 10.1161/JAHA.116.005251.
PubMed 28862959
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
- ClinicalTrials.gov ID
- NCT02671474
- Acronym / sponsor ID
- Perceval thrombosis
- Conditions
- Aortic Valve Stenosis, Heart Valve Disease
- 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
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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 leaflet motion. 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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Implanted with a sutureless Perceval (Sorin Group) 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 | Other | – |
Primary outcome
Reduced aortic valve leaflet motion
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 11 Jul 2016.
- Derived from this study: PubMed 28862959Dalen M, Sartipy U, Cederlund K, Franco-Cereceda A, Svensson A, Themudo R, Svenarud P, Bacsovics Brolin E. Hypo-Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves. J Am Heart Assoc. 2017 Aug 21;6(8):e005251. doi: 10.1161/JAHA.116.005251.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease, 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 11 Jul 2016. 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?
Reduced aortic valve leaflet motion (time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement). 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 NCT02671474, 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 11 Jul 2016.