Concomitant Tricuspid Repair in Patients With Left Heart Surgery

Sponsor

Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05595187

Collaborator

Affiliated Hospital of Nantong University (Other), The First Affiliated Hospital of Anhui Medical University (Other), Jiangsu Subei People Hospital (Other), Nanjing First Hospital, Nanjing Medical University (Other)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation Mitral Regurgitation Cardiopulmonary Bypass	Device: Tricuspid repair	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tricuspid repair 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.	Device: Tricuspid repair Tricuspid repair included suture placement and the type of prosthetic annuloplasty.
No Intervention: Blank control

Arm

Intervention/Treatment

Experimental: Tricuspid repair

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.

Device: Tricuspid repair

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

No Intervention: Blank control

Outcome Measures

Primary Outcome Measures

A composite of adverse cardiovascular events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing		China

Sponsors and Collaborators

Nanjing Medical University
Affiliated Hospital of Nantong University
The First Affiliated Hospital of Anhui Medical University
Jiangsu Subei People Hospital
Nanjing First Hospital, Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hong Liu, Principal Investigator of Cardiovascular Surgery, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05595187

Other Study ID Numbers:

JPH-2022

First Posted:

Oct 26, 2022

Last Update Posted:

Oct 26, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Oct 26, 2022