Concomitant Tricuspid Repair in Patients With Left Heart Surgery

Nanjing Medical University

Status: Not yet enrolling

Conditions: Cardiopulmonary Bypass; Mitral Regurgitation; Tricuspid Regurgitation

Treatments: Device: Tricuspid repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05595187

JPH-2022

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Tricuspid repair

Experimental group

Description:

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.

Treatment:

Device: Tricuspid repair

Blank control

No Intervention group