Concomitant Tricuspid Repair in Patients With Left Heart Surgery
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 14, 2023
December 1, 2023
2.7 years
October 23, 2022
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Tricuspid repair
EXPERIMENTALTricuspid 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.
Blank control
NO INTERVENTIONInterventions
Tricuspid repair included suture placement and the type of prosthetic annuloplasty.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator of Cardiovascular Surgery
Study Record Dates
First Submitted
October 23, 2022
First Posted
October 26, 2022
Study Start
May 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 14, 2023
Record last verified: 2023-12