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A multi-center prospective cohort study of the prognostic value of proportionate/disproportionate tricuspid regurgitation based on the ratio of vena contracta area to tricuspid annular area using three-dimensional echocardiography in isolated tricuspid valve surgery after left-sided valve surgery

A multi-center prospective cohort study of the prognostic value of proportionate/disproportionate tricuspid regurgitation based on the ratio of vena contracta area to tricuspid annular area using three-dimensional echocardiography in isolated tricuspid valve surgery after left-sided valve surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080183
Enrollment
Unknown
Registered
2024-01-23
Start date
2024-01-31
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid regurgitation

Interventions

Proportionate tricuspid regurgitation (Two and three-dimensional echocardiography examination performed one-day before surgery.):None
Disproportionate tricuspid regurgitation (Two and three-dimensional echocardiography examination performed one-day before surgery.):None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Underwent guideline-directed medical therapy for more than 3 months. 2. Severe and more-than-severe tricuspid regurgitation post-left heart valve surgery (meet with at least 2 of the following 3 criteria: coaptation gap width greater than 7mm, effective regurgitant orifice area greater than 0.4cm², regurgitant volume greater than 45ml). 3. ITVS candidates; 4. Aged = 18 years.

Exclusion criteria

Exclusion criteria: 1. History of coronary artery disease, including angina, myocardial infarction, post-coronary artery bypass graft surgery, or post-coronary stent implantation. 2. Pulmonary embolism or chronic obstructive pulmonary disease. 3. Tricuspid or pulmonary valve stenosis. 4. Mild or greater pulmonary valve regurgitation. 5. Moderate or greater left heart valve disease; 6. Left ventricular ejection fraction less than 40%; 7. Echocardiographic estimation of pulmonary artery systolic pressure greater than 55mmHg; 8. Expected lifespan less than 1 year, or anticipated inability to complete follow-up; 9. Unclear echocardiographic images.

Design outcomes

Primary

MeasureTime frame
VCA;Area of tricuspid annulus;All-cause mortality after surgery;

Secondary

MeasureTime frame
Area change of tricuspid annuls;Area of leaflet;Tenting height;Tenting volume;Left ventricular ejection fraction;Left ventricular global longitudinal strain;Left ventricular global constructive work;Left ventricular global wasted work;Left ventricular global circumferential strain;Left ventricular global radial strain;Left ventricular global area strain;Right ventricular ejection fraction;TAPSE;peak S';Right ventricular global longitudinal strain;Right ventricular free wall longitudinal strain;Tricuspid valve effective regurgitant orifice area;Tricuspid regurgitant volume ;Tricuspid regurgitant vena contracta width;pulmonary arterial systolic pressure;Accelerating time of pulmonary artery;Right ventricular global work efficiency;Right ventricular global constructive work;Right ventricular global wasted work;Right ventricular global circumferential strain;Right ventricular global radial strain;Right ventricualr global area strain;Right ventricular end-diastolic volume;Right ventricular end-systolic volume;Left atrial volume;Right atrial volume;Right atrial strain ;Left atrial strain ;Tricuspid regurgitation fraction;Decompensated heart failure;Cardiovascular readmission;Malignant arrhythmia;Cardiac arrest;Cardiogenic shock;Acute stroke;

Countries

China

Contacts

Public ContactLili Dong

Zhongshan Hospital, Fudan University

dong.lili@zs-hospital.sh.cn+86 139 1806 9867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026