Concomitant Tricuspid Repair in Patients With Left Heart Surgery

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiopulmonary Bypass Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency Tricuspid Valve Insufficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tricuspid repair

Device

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

Primary outcomes

A composite of adverse cardiovascular events

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

18801281613

Yong-feng Shao, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 26, 2022
Registry last updated: Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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