Tricuspid Valve InsufficiencyNCT01580436
Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
A study testing Tricuspid Valve Annuloplasty in people with Tricuspid Valve Insufficiency, run by Hasselt University at 1 site in Belgium.
Trial summary
De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Tricuspid Valve Annuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2011to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for mitral valve surgery
- Tricuspid Annular diameter > 40mm or >21mm/m²
Who cannot join
- Tricuspid Regurgitation more than 2+
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg (General Hospital Genk)
Genk, 3600
David Verhaert, MD, +32 089 32 70 91, david.verhaert@zol.be
Chris Beerts, +32 089 32 71 91, chris.beerts@zol.be
About this study
Official title: Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Tricuspid Valve Annuloplasty
- Keywords
- Tricuspid Valve Insufficiency, Cardiac Valve Annuloplasty, Outcome Assessment (Health Care)
- 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.
Tricuspid Valve AnnuloplastyProcedure or surgery
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid Valve Annuloplasty | Experimental | Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty. Receives: Procedure: Tricuspid Valve Annuloplasty |
| Conservative arm | No intervention | Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to mitral valve surgery without concomitant tricuspid valve annuloplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
combination of all-cause mortality or heart failure hospitalisation
Measured: at 12 months post-surgery
Secondary outcomes (8)
RV function & geometry
volumes and ejection fraction Assessed by cardiac ultrasound and MRI
Measured: 3, 6, 12 and 18 months
Quality of Life
Change at follow-up, measured by SF-36 \& Minnesota Living with Heart Failure scale.
Measured: 6, 12 and 18 months
Duration of Hospital and ICU stay
Measured: postoperative phase
All-Cause Mortality
Measured: at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure
Measured: at 3, 6, 12 and 18 months post-surgery
progressive TR > 2+ post-surgery
Measured: 3, 6, 12 and 18 months
cardiovascular mortality
Measured: at 3, 6, 12 and 18 months post-surgery
Exercise Tolerance
Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2017 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfried Mullens, MD PhD, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580436
- Sponsor's protocol ID
- TVP Study
- Status last verified
- Oct 2014
- First submitted
- 18 Oct 2011
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT01580436
- Acronym / sponsor ID
- TVP Study
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- Tricuspid Valve Insufficiency, Cardiac Valve Annuloplasty, Outcome Assessment (Health Care)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2017 (estimated)
- First posted
- 19 Apr 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.
De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tricuspid Valve Annuloplasty | Experimental | Procedure: Tricuspid Valve AnnuloplastyPatients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty. |
| Conservative arm | No intervention | –Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to mitral valve surgery without concomitant tricuspid valve annuloplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for mitral valve surgery
- Tricuspid Annular diameter > 40mm or >21mm/m²
Key exclusion criteria (2 listed)
- Tricuspid Regurgitation more than 2+
- Unable to provide informed 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 |
|---|---|---|
| Tricuspid Valve AnnuloplastyConcomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery | Procedure or surgery | Tricuspid Valve Annuloplasty |
Primary outcome
combination of all-cause mortality or heart failure hospitalisation
Time frame: at 12 months post-surgery
8 secondary outcomes
RV function & geometry
Time frame: 3, 6, 12 and 18 months
Quality of Life
Time frame: 6, 12 and 18 months
Duration of Hospital and ICU stay
Time frame: postoperative phase
All-Cause Mortality
Time frame: at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure
Time frame: at 3, 6, 12 and 18 months post-surgery
progressive TR > 2+ post-surgery
Time frame: 3, 6, 12 and 18 months
cardiovascular mortality
Time frame: at 3, 6, 12 and 18 months post-surgery
Exercise Tolerance
Time frame: 6, 12 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid Valve Annuloplasty in people with Tricuspid Valve Insufficiency, run by Hasselt University 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 2 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: status not confirmed, as of the sponsor's last update on 24 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Verhaert, MD (+32 089 32 70 91, david.verhaert@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combination of all-cause mortality or heart failure hospitalisation (time frame: at 12 months post-surgery). 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 24 Oct 2014.