Cardiopulmonary Bypass, Mitral Regurgitation, Tricuspid Regurgitation
Conditions
Brief 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 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
DEVICETricuspid repair
Tricuspid repair included suture placement and the type of prosthetic annuloplasty.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing left heart valve surgery with mild tricuspid regurgitation; 2. Patients aged 18-80 years; 3. Agree to participate in this study and sign the informed consent form.
Exclusion criteria
1. Infective endocarditis within 3 months; 2. Primary tricuspid regurgitation; 3. Isolated tricuspid regurgitation 4. Lactating women and suspected pregnant or pregnant women; 5. Patients with mental disorders, drug and alcohol dependence; 6. Those who participated in other clinical trials one month before the trial; 7. Refusal to participate in this study without informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A composite of adverse cardiovascular events | 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. |
Countries
China
Contacts
Primary ContactHong Liu, MD
Backup ContactYong-feng Shao, MD
Outcome results
None listed