Tricuspid (Valve); DeformityNCT02357862
Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty
An observational study of Tricuspid (Valve); Deformity, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid (Valve); Deformity
- What is being tested?
- Mitral Valve Annuloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2016
- 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 undergoing minimally invasive, isolated mitral valve annuloplasty in the University Hospitals Leuven
Who may be able to join
- all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty
Who cannot join
- concomitant tricuspid valve surgery
- atrial fibrillation at the moment of surgery
- poor echocardiographic windows
About this study
Official title: Impact of Mitral Valve Annuloplasty on the Tricuspid Valve Complex
The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.
Read the detailed description
The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.
- Conditions
- Tricuspid (Valve); Deformity
- Being tested
- Mitral Valve Annuloplasty
- Keywords
- Cardiovascular Diseases, Heart Valve Diseases, Mitral Valve Annuloplasty, Tricuspid Valve Insufficiency
- Medical subject headings
- Congenital Abnormalities, Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve AnnuloplastyProcedure or surgery
Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Annuloplasty | All eligible patients Receives: Procedure: Mitral Valve Annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative geometric changes in tricuspid valve annulus (TA)
Measurement of changes in 3D descriptors of the TA (e.g. changes from baseline in the TA area of the best-fit plane in cm^2, and changes from baseline in the height of each TA point to the TA best-fit plane in mm)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid (Valve); DeformityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Budts, M.D., PhD, Principal investigator, KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357862
- Sponsor's protocol ID
- MVR_TV
- Status last verified
- Jul 2015
- First submitted
- 26 Jan 2015
- Last updated
- 8 May 2018
- 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 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mitral Valve Annuloplasty on the Tricuspid Valve Complex
- ClinicalTrials.gov ID
- NCT02357862
- Acronym / sponsor ID
- MVR_TV
- Conditions
- Tricuspid (Valve); Deformity
- Keywords
- Cardiovascular Diseases, Heart Valve Diseases, Mitral Valve Annuloplasty, Tricuspid Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Feb 2015 (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.
The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.
Detailed description
The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Annuloplasty | – | Procedure: Mitral Valve AnnuloplastyAll eligible patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing minimally invasive, isolated mitral valve annuloplasty in the University Hospitals Leuven
Key inclusion criteria (1 listed)
- all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty
Key exclusion criteria (3 listed)
- concomitant tricuspid valve surgery
- atrial fibrillation at the moment of surgery
- poor echocardiographic windows
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 |
|---|---|---|
| Mitral Valve AnnuloplastyMitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion | Procedure or surgery | Mitral Valve Annuloplasty |
Primary outcome
Postoperative geometric changes in tricuspid valve annulus (TA)
Time frame: day 0
Measurement of changes in 3D descriptors of the TA (e.g. changes from baseline in the TA area of the best-fit plane in cm^2, and changes from baseline in the height of each TA point to the TA best-fit plane in mm)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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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.
Werner Budts, M.D., PhD principal investigator
KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid (Valve); Deformity, run by Universitaire Ziekenhuizen KU Leuven.
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 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: stopped early, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Postoperative geometric changes in tricuspid valve annulus (TA) (time frame: day 0). 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 8 May 2018.