Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Fudan University

Status

Enrolling

Conditions

Tricuspid Regurgitation

Treatments

Procedure: Minimally Invasive Tricuspid Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04339192

B2020-036R

Details and patient eligibility

About

Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage. Over the past 3 decades, with the advances in minimally invasive surgical techniques, operative mortality after reoperation for severe TR has significantly decreased from 30% to 3-8%, leading to a gradual shift from medical therapy alone to surgery in those patients. However, there has been no consensus on the clinical benefit of minimally invasive tricuspid surgery over medical therapy for severe TR after LSVS.

Full description

In this multi-center randomized controlled trial, patients with severe TR after LSVS will be recruited. The patients will be randomly assigned to surgery plus medical therapy (surgery group) or medical therapy alone (control group). The primary outcome will be a composite of all-cause mortality, re-admission for right heart failure or the composite. Furthermore, echocardiography-based measurement of right heart function, New York Heart Association functional class, liver and kidney function, and quality of life will be compared between the 2 groups. All outcomes will be assessed at baseline and 6, 12 and 24 months after randomization.

Enrollment

330 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography.
A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement.
Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60 mmHg with pulmonary vascular resistance <6 woods unit.
Age ≥ 18 years.
Able to sign Informed Consent forms.

Exclusion criteria

TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease.
Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures.
Prior surgical or percutaneous tricuspid valve intervention.
Evidence of an acute myocardial infarction in the prior 90 days
Contraindications to cardiopulmonary bypass or the expected operative mortality >30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).
Any comorbidity with life expectancy <2 years
Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol.
Pregnancy at the time of randomization.