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Concomitant Tricuspid Repair in Patients With Left Heart Surgery

NCT ID: NCT05595187

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tricuspid Regurgitation Mitral Regurgitation Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tricuspid repair

Intervention Type DEVICE

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

Blank control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tricuspid repair

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Principal Investigator of Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

Phone: 18801281613

Email: [email protected]

Yong-feng Shao, MD

Role: CONTACT

Phone: 02568303101

Email: [email protected]

Other Identifiers

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JPH-2022

Identifier Type: -

Identifier Source: org_study_id