Concomitant Tricuspid Repair in Patients With Left Heart Surgery

Mitral Regurgitation Clinical Trial

Official title:

Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05595187
• Other study ID #: JPH-2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: 18801281613
• Email: dr.hongliu[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Tricuspid repair
Tricuspid repair included suture placement and the type of prosthetic annuloplasty.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years after surgery at follow-up