Back to resultsConcomitant Tricuspid Repair in Patients With Left Heart Surgery
Primary Purpose
Tricuspid Regurgitation, Mitral Regurgitation, Cardiopulmonary Bypass
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tricuspid repair
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation
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.
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tricuspid repair
Blank control
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05595187
First Posted
October 23, 2022
Last Updated
October 23, 2022
Sponsor
Nanjing Medical University
Collaborators
Affiliated Hospital of Nantong University, The First Affiliated Hospital of Anhui Medical University, Jiangsu Subei People Hospital, Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05595187
Brief Title
Concomitant Tricuspid Repair in Patients With Left Heart Surgery
Official Title
Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
Affiliated Hospital of Nantong University, The First Affiliated Hospital of Anhui Medical University, Jiangsu Subei People Hospital, Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Mitral Regurgitation, Cardiopulmonary Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tricuspid repair
Arm Type
Experimental
Arm 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.
Arm Title
Blank control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Tricuspid repair
Intervention Description
Tricuspid repair included suture placement and the type of prosthetic annuloplasty.
Primary Outcome Measure Information:
Title
A composite of adverse cardiovascular events
Description
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.
Time Frame
2 years after surgery at follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu, MD
Phone
18801281613
Email
dr.hongliu@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-feng Shao, MD
Phone
02568303101
Email
yfshaojph@sina.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Concomitant Tricuspid Repair in Patients With Left Heart Surgery
We'll reach out to this number within 24 hrs