Tricuspid Valve InsufficiencyNCT01537458
Long-term Outcome After Isolated Tricuspid Valve Repair
An observational study of Tricuspid Valve Insufficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- follow-up of isolated tricuspid valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Mar 2012to 1 Mar 2013
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing isolated tricuspid valve repair
Who may be able to join
- tricuspid valve insufficiency
Who cannot join
- younger than 18 years
- associated valvular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.
The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- follow-up of isolated tricuspid valve repair
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up of isolated tricuspid valve repairProcedure or surgery
follow-up of patients that underwent TV repair in the past.
| Study group | Role | What they receive |
|---|---|---|
| Isolated TI repair | Patients that underwent isolated tricuspid valve repair Receives: Procedure: follow-up of isolated tricuspid valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 10 year
Redo surgery
Measured: 10 year
Secondary outcomes (4)
functional capacity assessed by CPET
Measured: 10 year
Atrial fibrillation
Measured: 10 year
Hospitalisation
hospitalisation for cardiovascular reasons
Measured: 10 year
Functional capacity assessed by NYHA functional class
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study start19 Mar 2012
- Primary completion30 Jun 2012
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies 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
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537458
- Sponsor's protocol ID
- Is_TVR_1
- Status last verified
- Feb 2012
- First submitted
- 13 Feb 2012
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome After Isolated Tricuspid Valve Repair
- ClinicalTrials.gov ID
- NCT01537458
- Acronym / sponsor ID
- Is_TVR_1
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 19 Mar 2012 (actual)
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 23 Feb 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.
Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.
The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated TI repair | – | Procedure: follow-up of isolated tricuspid valve repairPatients that underwent isolated tricuspid valve repair |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing isolated tricuspid valve repair
Key inclusion criteria (1 listed)
- tricuspid valve insufficiency
Key exclusion criteria (2 listed)
- younger than 18 years
- associated valvular surgery
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 |
|---|---|---|
| follow-up of isolated tricuspid valve repairfollow-up of patients that underwent TV repair in the past. | Procedure or surgery | Isolated TI repair |
Primary outcome
mortality
Time frame: 10 year
Redo surgery
Time frame: 10 year
4 secondary outcomes
functional capacity assessed by CPET
Time frame: 10 year
Atrial fibrillation
Time frame: 10 year
Hospitalisation
Time frame: 10 year
Functional capacity assessed by NYHA functional class
Time frame: 10 years
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 27 Jan 2023.
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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?
An observational study of Tricuspid Valve Insufficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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 27 Jan 2023. 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 Belgium. 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?
mortality (time frame: 10 year). 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?
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 27 Jan 2023.