Tricuspid valve regurgitation of grade 0-1 with annular dilation
Conditions
Interventions
Experimental Group:Participants underwent conventional mitral valve surgery and tricuspid valve repair with tricuspid valve circuit at the same time
Control group:Participants underwent conventional mitral valve surgery.
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) The subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent form before the start of the trial; 2) Elective mitral valve open surgery (including radiofrequency ablation of atrial fibrillation); 3) Preoperative echocardiography showed tricuspid regurgitation of 0-1 degree and tricuspid valve annular diameter >4cm; 4) Preoperative NYHA cardiac function grade III and below (including grade III); 5) The subject can communicate well with the investigator, and understand and comply with the requirements of this study. (All of the above requirements must be met to be included in the trial)
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to tricuspid valve implantation or those who have previously undergone tricuspid valve surgery/intervention; 2) Previous history of cardiac surgery; 3) Aortic valve surgery or coronary artery bypass surgery is required at the same time; 4) Severe respiratory dysfunction; 5) Preoperative echocardiography showed tricuspid regurgitation >=2 degrees; 6) Severe congenital/organic tricuspid valve disease; 7) Previous history of pulmonary embolism/pulmonary vascular/primary pulmonary hypertension 8) Cerebrovascular events within 3 months prior to surgery; 9) Restrictive or hypertrophic cardiomyopathy, structural pericarditis or other structural heart disease; 10) Patients with severe renal insufficiency (defined as glomerular filtration rate 2.5 mg/dl (221 micromol/L); 11) Anemia that cannot be improved by blood transfusion (hemoglobin 750×10^9/L); 12) Patients with definite coagulation dysfunction and severe bleeding disorders; 13) Patients with active peptic ulcer or active gastrointestinal bleeding; 14) Contraindications to anticoagulation or antiplatelet therapy; 15) Active infective endocarditis; 16) Patients with known allergies to nitinol and contrast media; 17) Pregnant and lactating females; 18) The subject may not be able to follow the protocol to complete this study due to other reasons or the investigator judges that it is not suitable for participation. (If any of the above items are met, they will not be included in the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reoperation was performed due to tricuspid regurgitation;The degree of tricuspid regurgitation progressed two grades from baseline or progressed to severe or above tricuspid regurgitation;Death; | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of tricuspid regurgitation was graded;Right atrial area (RA);Right ventricular area (RV);Tricuspid annular systolic excursion (TAPSE) (preoperative), FAC (postoperative);Right ventricular ejection fraction (RVEF);NYHA cardiac function classification;Improvements in quality of life;The frequency of postoperative atrial fibrillation;Rates of serious adverse events;Other adverse events were recorded up to 30 days after surgery.; | — |
Countries
China
Contacts
Public ContactJianggang Wang
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed