Status:
UNKNOWN
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 medica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04339192
Start Date
May 1 2020
End Date
June 1 2024
Last Update
April 9 2020
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032