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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery group | Experimental | receiving minimally invasive tricuspid surgery including tricuspid valve replacement or repair plus medical treatment. |
|
| Medical group | No Intervention | receiving medical treatment only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Tricuspid Surgery | Procedure | minimally invasive tricuspid surgery including endoscopy-assist right minithoracotomy, vacuum-assist single femoral venous drainage without dissecting or snaring vena cava, direct right atriotomy through pericardium and the beating-heart technique. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of all-cause death, re-hospitalization due to right heart failure or both of them | the rate of all-cause death, re-hospitalization due to right heart failure or both of them | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| right heart function | echocardiography-based measurement of right heart function | 2 years |
| New York Heart Association functional class | New York Heart Association functional class including I, II, III, IV class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinmiao Chen, MD, PhD | Contact | +86 15121036927 | chen.jinmiao@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chunsheng Wang, MD | Zhongshan Hospital, Fudan Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31157373 | Background | 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. |
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Now we have decided not to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 2 years |
| liver function | total bilirubin, conjugated bilirubin | 2 years |
| liver function | prealbumin. | 2 years |
| kidney function | blood urea nitrogen | 2 years |
| kidney function | creatinine | 2 years |
| kidney function | uric acid. | 2 years |
| life quality scores | quality of life using the SF-12 form | 2 years |