Heart Failure
Conditions
Interventions
Case series:Implantation of atrial shunt device
Sponsors
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology/ Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old; 2. The subject himself or his legal representative sign the informed consent form, fully understand the nature and requirements of the study, is willing to follow the clinical investigation procedures, and agree to return for all necessary follow-up inquiries, tests and inspections; 3. Patients with NYHA grade II-IV chronic heart failure who still have symptoms after at least 4 weeks of standardized drug treatment (gdmt); 4. There is a pressure gradient in the left and right atrium measured by invasive hemodynamics: mpcwp / mlap MRAP pressure difference >=5mmhg.
Exclusion criteria
Exclusion criteria: 1. Subjects in stage D of heart failure, IV grade of resting state of New York Heart function, unable to tolerate any physical activity (6-minute walking distance less than 50 meters), continuous or intermittent intravenous medication; 2. Subjects who have planned or received cardiac resynchronization therapy, ventricular assist devices and heart transplantation; 3. Subjects who had a history of myocardial infarction and / or cardiac surgery, deep vein thrombosis and pulmonary embolism, transient ischemic attack, stroke, severe deep hemorrhage, or received local / systemic thrombolysis or other major surgical operations within 3 months; 4. Subjects with hypertrophic obstructive cardiomyopathy, intracardiac tumor, valvular heart disease, congenital heart disease, aortic disease, severe coronary artery disease, giant ventricular aneurysm, constrictive pericarditis, massive pericardial effusion or pericardial tamponade, cerebrovascular disease and peripheral vascular disease requiring surgical intervention; 5. The imaging results showed that the patients with right ventricular systolic or diastolic dysfunction, right atrial and right ventricular dilation and severe pulmonary hypertension; 6. Subjects who had previous high risk factors of sudden death such as multiple syncope, history of cardiac arrest and repeated ventricular tachycardia but did not implant ICD; 7. Subjects with intracardiac thrombosis or mass; 8. Subjects whose anatomy is abnormal and the operation cannot be completed or who are not anatomically suitable for the operation (such as swinging atrial septal expansion tumor, absence of inferior vena cava liver segment, etc.); 9. Subjects with ASD of more than 5mm or with history of implantation of ASD / patent foramen ovale occlusion device; 11. Subjects with bleeding tendency, coagulation dysfunction or other antiplatelet and anticoagulation Taboos; 12. Subjects with active peptic ulcer or upper gastrointestinal bleeding within 3 months; 13. Subjects with life expectancy less than 1 year due to non cardiovascular diseases; 14. The subjects who are pregnant or lactating, and the women of childbearing age plan to be pregnant in the near future; 15. Subjects with severe hepatorenal dysfunction, obstructive or restrictive respiratory dysfunction, malignant tumor, coma, paraplegia, hemiplegia, etc; 16. Patients who are allergic to contrast agents, anesthetics, antiplatelet drugs, anticoagulants, nickel titanium metal materials or have contraindications; 17. Patients with severe anxiety, depression and other mental diseases, dementia and other cognitive dysfunction, or patients who the researchers think have poor compliance and can not cooperate with follow-up visit; 18. Subjects with immunodeficiency and undergoing immunosuppression or systemic hormone therapy; 19. Subjects with local or systemic infection, septicemia, infective endocarditis, etc; 20. Subjects currently participating in clinical trials of other drugs or medical devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardio cerebral renal events within 6 months after operation;Effective shunt rate under echocardiography at the end of 6 months after operation;successful operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Readmission and death associated with worsening cardiac function;Changes of NT-proBNP at 6 months after operation compared with baseline;Changes of hemodynamic indexes at 6 months after operation compared with baseline;Changes of echocardiographic indexes at 6 months after operation compared with baseline;Comparison of cardiopulmonary exercise test, 6-minute walking distance, New York Heart Association grade and Kansas City Cardiomyopathy Questionnaire at 6 months and baseline; | — |
Countries
China
Contacts
Public ContactNianguo Dong
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed