Concomitant Tricuspid Repair in Patients With Left Heart Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tricuspid repair.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Mitral Regurgitation, Cardiopulmonary Bypass. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
Overview
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.
Interventions
- Device Tricuspid repair
Tricuspid repair included suture placement and the type of prosthetic annuloplasty.
Primary outcome measures
- A composite of adverse cardiovascular events [Time frame: 2 years after surgery at follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT05595187 · JPH-2022