Tricuspid RegurgitationNCT05595187
Concomitant Tricuspid Repair in Patients With Left Heart Surgery
A study testing Tricuspid repair in people with Tricuspid Regurgitation and Mitral Regurgitation, run by Nanjing Medical University at 1 site in China.
Trial summary
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tricuspid Regurgitation, Mitral Regurgitation, Cardiopulmonary Bypass
- What is being tested?
- Tricuspid repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing left heart valve surgery with mild tricuspid regurgitation;
- Patients aged 18-80 years;
- Agree to participate in this study and sign the informed consent form.
Who cannot join
- Infective endocarditis within 3 months;
- Primary tricuspid regurgitation;
- Isolated tricuspid regurgitation
- Lactating women and suspected pregnant or pregnant women;
- Patients with mental disorders, drug and alcohol dependence;
- Those who participated in other clinical trials one month before the trial;
- Refusal to participate in this study without informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.
- Being tested
- Tricuspid repair
- Medical subject headings
- Tricuspid Valve Insufficiency, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid repairDevice
Tricuspid repair included suture placement and the type of prosthetic annuloplasty.
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid repair | Experimental | Tricuspid repair techniques included suture placement and the type of prosthetic annuloplasty with specified the use of an approved rigid, incomplete, nonplanar, and undersized (ranging 26, 28, or 30, 32, 34 mm) ring. Receives: Device: Tricuspid repair |
| Blank control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of adverse cardiovascular events
a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation from baseline by two grades or the presence of severe tricuspid regurgitation, or death.
Measured: 2 years after surgery at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595187
- Sponsor's protocol ID
- JPH-2022
- Status last verified
- Dec 2023
- First submitted
- 23 Oct 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05595187
- Acronym / sponsor ID
- JPH-2022
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2022 (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.
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tricuspid repair | Experimental | Device: Tricuspid repairTricuspid repair techniques included suture placement and the type of prosthetic annuloplasty with specified the use of an approved rigid, incomplete, nonplanar, and undersized (ranging 26, 28, or 30, 32, 34 mm) ring. |
| Blank control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing left heart valve surgery with mild tricuspid regurgitation;
- Patients aged 18-80 years;
- Agree to participate in this study and sign the informed consent form.
Key exclusion criteria (7 listed)
- Infective endocarditis within 3 months;
- Primary tricuspid regurgitation;
- Isolated tricuspid regurgitation
- Lactating women and suspected pregnant or pregnant women;
- Patients with mental disorders, drug and alcohol dependence;
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 repairTricuspid repair included suture placement and the type of prosthetic annuloplasty. | Device | Tricuspid repair |
Primary outcome
A composite of adverse cardiovascular events
Time frame: 2 years after surgery at follow-up
a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation from baseline by two grades or the presence of severe tricuspid regurgitation, or death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 repair in people with Tricuspid Regurgitation and Mitral Regurgitation, run by Nanjing Medical University at 1 site in China.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Dec 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (18801281613, dr.hongliu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of adverse cardiovascular events (time frame: 2 years after surgery at follow-up). 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 14 Dec 2023.