Heart failure and pulmonary hypertension
Conditions
Interventions
experimental group:Percutaneous and transcatheter atrial shunt
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, and gender is unlimited; 2. The subject has signed the informed consent form, fully understands the nature and requirements of the study, is willing to comply with the clinical investigation procedures, and agrees to return for all necessary follow-up inquiry / tests and examinations; 3. Patients with chronic heart failure who retain or decrease their ejection fraction from grade NYHA III to non-bedridden grade IV or patients with pulmonary hypertension who remain symptomatic after optimized drug treatment.
Exclusion criteria
Exclusion criteria: 1. Non-negative pregnancy test women of childbearing age, lactating women, or plan to get pregnant within six months; 2. EF <= 20%; 3. Invasive hemodynamic measurement of the left and right ventricular pressure gradient: mPCWP / mLAP-mRAP pressure difference < 5 mmHg; 4. Myocardial infarction and / or percutaneous cardiac intervention in the past 1 month; Severe coronary artery disease requiring surgical intervention, including coronary bypass grafting or current indications for coronary revascularization; 5. There are already atrial level, chamber level, large artery level of the shunt; 6. Cardiac resynchronization treatment began within the past 6 months; 7. A 6-minute walk test cannot be performed; 8. Echocardiography was identified as a severe valvular disease requiring surgical intervention; 9. Echocardiography showed a new luminal mass and thrombus; 10. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other invasive cardiomyopathy; 11. Allergy or contraindications to contrast agents, anesthetics, niti-titanium metal materials, antiplatelet therapy or anticoagulant therapy; 12. Severe abnormal liver and renal function, respiratory failure or significant chronic lung disease (aggravated hospitalization in the previous 6 months), coma, paraplegia, hemiplegia; 13. The imaging results indicate severe right ventricular or diastolic dysfunction, obvious right ventricular dilatation of the right atrium, and severe pulmonary hypertension (pulmonary artery systolic pressure of 50mmHg); 14. TIA, cerebral infarction, and DVT / PE in the past 6 months; 15. Life expectancy of non-cardiovascular disease causes (such as malignancy) is less than 12 months; 16. Local or systemic infection activity period, sepsis, infective endocarditis; 17. Participated in clinical trials of other drugs or medical devices (except for registered studies) within 3 months before enrollment; 18. Subjects not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate postoperative surgical success rate;heart catheterization; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 minutes walking distance;Kansas City Cardiomyopathy Questionnaire;New York Heart Association;transesophageal echocardiography;Transesophageal echocardiography;Plasma NT-proBNP /BNPlevel; | — |
Countries
China
Contacts
Public ContactYuan Feng
West China Hospital of Sichuan University
Outcome results
None listed