Clinical trial NCT04339192: Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
Official title: Minimally Invasive Tricuspid Surgery Versus Medical Treatment for Severe Tricuspid Regurgitation After Left-sided Valve Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: the rate of all-cause death, re-hospitalization due to right heart failure or both of them
timeFrame: 2 years
Secondary outcomes:
measure: right heart function
timeFrame: 2 years
measure: New York Heart Association functional class
timeFrame: 2 years
measure: liver function
timeFrame: 2 years
measure: liver function
timeFrame: 2 years
measure: kidney function
timeFrame: 2 years
measure: kidney function
timeFrame: 2 years
measure: kidney function
timeFrame: 2 years
measure: life quality scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan Univerisity
name: Chunsheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen J, Hu K, Ma W, Lv M, Shi Y, Liu J, Wei L, Lin Y, Hong T, Wang C. Isolated reoperation for tricuspid regurgitation after left-sided valve surgery: technique evolution. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):142-150. doi: 10.1093/ejcts/ezz160.