Barlow Disease (BD)NCT04418960
Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease
An observational study of Barlow Disease (BD) and Mitral Insufficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barlow Disease (BD), Mitral Insufficiency
- What is being tested?
- Magnetic resonance imaging (MRI)
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2018to Apr 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 referred to cardiac surgery clinic (University Hospital Basel) through cardiologist meeting the inclusion criteria based on the medical history, clinical and echocardiographic findings.
Who may be able to join
- identified Barlow disease suffering from significant mitral insufficiency with indication to surgery
Who cannot join
- Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease
- Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia)
- Pregnancy
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Cardiac Surgery, University Hospital Basel
Basel, 4031
Martin Grapow, Prof. Dr. med., +41 44 3873711, grapow@herzzentrum.ch
Thibault Schaeffer, +41 61 3285766, Thibault.Schaeffer@usb.ch
About this study
Official title: Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study
Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.
- Conditions
- Barlow Disease (BD), Mitral Insufficiency
- Being tested
- Magnetic resonance imaging (MRI)
- Keywords
- mitral annuloplasty, mitral valve repair, mitral annulus, coaptation of mitral leaflets
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anatomical structures by MRI
Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction
Measured: The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.
Secondary outcomes (1)
function of the mitral valve by echocardiography
association between reduction of movement of the posterior annulus and the function of the valve after surgery (i.e. its residual insufficiency (0 = absent, 1 = mild, 2 = moderate, 3 = severe)). Evaluated with echocardiography as it is routinely performed in cardiac surgery.
Measured: during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start21 Sep 2018
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barlow Disease (BD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grapow, Prof. Dr. med., Principal investigator, HerzZentrum Hirslanden, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418960
- Sponsor's protocol ID
- 2018-02240; ch20Grapow
- Other IDs
- 2018
- Status last verified
- Aug 2021
- First submitted
- 12 May 2020
- Last updated
- 3 Aug 2021
- 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 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study
- ClinicalTrials.gov ID
- NCT04418960
- Acronym / sponsor ID
- 2018-02240; ch20Grapow
- Conditions
- Barlow Disease (BD), Mitral Insufficiency
- Keywords
- mitral annuloplasty, mitral valve repair, mitral annulus, coaptation of mitral leaflets
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 5 Jun 2020 (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.
Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to cardiac surgery clinic (University Hospital Basel) through cardiologist meeting the inclusion criteria based on the medical history, clinical and echocardiographic findings.
Key inclusion criteria (1 listed)
- identified Barlow disease suffering from significant mitral insufficiency with indication to surgery
Key exclusion criteria (4 listed)
- Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease
- Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia)
- Pregnancy
- Inability to give consent
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist. | Diagnostic test | – |
Primary outcome
Change in anatomical structures by MRI
Time frame: The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.
Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction
1 secondary outcome
function of the mitral valve by echocardiography
Time frame: during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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.
Martin Grapow, Prof. Dr. med. principal investigator
HerzZentrum Hirslanden, Zurich
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 Barlow Disease (BD) and Mitral Insufficiency, 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 1 inclusion and 4 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 3 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Grapow, Prof. Dr. med. (+41 44 3873711, grapow@herzzentrum.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anatomical structures by MRI (time frame: The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.). 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 3 Aug 2021.