Aortic Valve StenosisNCT01707927
Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.
An observational study of Aortic Valve Stenosis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated elektively for aortic valve disease with the need of a biological valve
Who may be able to join
- Aortic valve disease
Who cannot join
- Pregnant
- Breast feeding
- Aortic valve bigger than 23 mm
- Endocarditis
- EF < 50%
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo university hospital, Thoracic departement
Oslo
Bjørn Braathen, MD. PhD, 004722118080, uxjrbr@uus-hf.no
Theis Tønnessen, MD, PhD, 004722118080, uxthto@uus-hf.no
About this study
Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.
- Conditions
- Aortic Valve Stenosis
- Keywords
- EOA
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Trifecta | Degenerated aortic valve with indication for aortic valve replacement | |
| mosaic Ultra | Need a aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure gradients
Investigators want too look at the effient opening area and pressure gradients of the two valves we are implanting on patients with the same size of the annulus.
Measured: 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionDec 2022 (estimated)
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.
- More trials run by Oslo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørn Braathen, Oslo University Hospital
- Investigators
- Bjørn Braathen, MD Ph.D, Principal investigator, OUS Thoraxkirurgisk avdeling UllevålTheis Tønnessen, MD Ph.D, Study director, OUS thoraxkirurgisk avdeling Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707927
- Sponsor's protocol ID
- 2011/2596/REK
- Status last verified
- Oct 2014
- First submitted
- 12 Sep 2012
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.
- ClinicalTrials.gov ID
- NCT01707927
- Acronym / sponsor ID
- 2011/2596/REK
- Conditions
- Aortic Valve Stenosis
- Keywords
- EOA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Oct 2012 (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.
Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifecta | – | –Degenerated aortic valve with indication for aortic valve replacement |
| mosaic Ultra | – | –Need a aortic valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated elektively for aortic valve disease with the need of a biological valve
Key inclusion criteria (1 listed)
- Aortic valve disease
Key exclusion criteria (5 listed)
- Pregnant
- Breast feeding
- Aortic valve bigger than 23 mm
- Endocarditis
- EF < 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure gradients
Time frame: 240 days
Investigators want too look at the effient opening area and pressure gradients of the two valves we are implanting on patients with the same size of the annulus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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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.
Bjørn Braathen, MD Ph.D principal investigator
OUS Thoraxkirurgisk avdeling Ullevål
Theis Tønnessen, MD Ph.D study director
OUS thoraxkirurgisk avdeling Ullevål
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 Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Oct 2014. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bjørn Braathen, MD Ph.D (0047 22118080 ext. 19703, uxjrbr@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure gradients (time frame: 240 days). 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 15 Oct 2014.