Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- Nanjing Medical University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- A composite of adverse cardiovascular events
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Hong Liu
Principal Investigator of Cardiovascular Surgery
Nanjing Medical University
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.
Outcomes
Primary Outcomes
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.