Heart failure
Conditions
Interventions
Experimental group:Atrial shunt surgery was performed on subjects using test instruments
Sponsors
Beijing Anzhen Hospital affiliated to Capital Medical University, Fuwai Cardiovascular Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old= age = 75 years old, gender is not limited (2) Left ventricular ejection fraction> 40% (3) BNP > 70 pg/mL or NT-Pro BNP >200 pg/mL in patients with sinus rhythm, BNP > 200 pg/mL or NT-Pro BNP>600 pg/mL in patients with atrial fibrillation (4) At least one hospitalization due to heart failure as the primary cause in the 12 months prior to surgery (5) Patients with chronic heart failure who are symptomatic despite adequate medication, New York Grade III and ambulatory Grade IV and have been stable for at least 1 month (6) The pressure difference between PCWP and RAP in the resting state is = 5mmHg (7) The subject voluntarily participates in the trial, the subject himself or his guardian signs the informed consent form, and the subject is able and willing to comply with all requirements, including follow-up and evaluation
Exclusion criteria
Exclusion criteria: (1) Patients with severe heart failure with one or more of the following conditions: a. Bedridden NYHA class IV heart failure b. Patients expected to have a heart transplant (2) Patients with atrial septal defects (3) The 6-minute walking test or the 6-minute walking distance 600 m, cannot be performed (4) Patients who plan to undergo coronary revascularization (5) Patients with myocardial infarction, percutaneous cardiac intervention or coronary artery bypass grafting within 1 month (6) Patients with a history of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolism within 3 months (7) Patients who have undergone cardiac resynchronization therapy or implanted cardioverter defibrillator (ICD) within 3 months (8) Echocardiography identified as a serious valvular disease requiring surgical intervention (9) Patients with echocardiography showing atrial masses and thrombosis (10) Patients with hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (11) Patients who are allergic to or have contraindications to contrast agents, anesthetics, antiplatelet therapy or anticoagulation therapy (12) Patients with severe liver and kidney dysfunction, respiratory failure, coma, paraplegia, and hemiplegia (13) Combined with clear right heart failure (such as blood congestion, recurrent lower extremity edema or polyserous cavity effusion, or imaging shows right ventricular diameter>left ventricle, tricuspid annular systolic motion range 14 mmHg at rest) (14) Patients with catheter measurement of pulmonary artery systolic blood pressure > 70 mmHg or pulmonary artery average pressure > 50mmHg (15) Patients with active local or systemic infection, sepsis, infective endocarditis (16) Patients with a life expectancy of less than 12 months due to non-cardiovascular disease causes (such as malignant tumors). (17) Pregnant or lactating women, or patients planning to become pregnant within 1 year (18) Patients who are participating in clinical trials of other drugs or medical devices (19) Patients who the investigator deems unsuitable for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate at 90 days postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;Effective shunt rate at 90 days postoperatively;Echocardiographic changes were compared with baseline 90 days postoperatively;Changes in pulmonary capillary wedge pressure (PCWP) were compared with baseline 90 days postoperatively;The 6-minute walking distance (6MWD) change value was compared with baseline 90 days postoperatively;Ninety days postoperatively, New York Cardiac Function Grading (NYHA) values were compared with baseline;Changes in Kansas Cardiomyopathy Questionnaire (KCCQ) scores were compared to baseline 90 days postoperatively;Serum brain natriuretic peptide (BNP) and N-terminal B-type brain natriuretic peptide precursor (NTproBNP) were compared with baseline at 90 days postoperatively;The incidence of major cardio-cerebral renal adverse events (MACCRE) at 90 days postoperatively;Incidence of device defects;Survival rate for no heart failure events within 90 days after surgery;Incidence of cardiac death within 90 days of surgery;Device-related adverse events and serious adverse events;Other adverse events and serious adverse events during the study period; | — |
Countries
China
Contacts
Public ContactGuangyuan Song, Jianzeng Dong; Yongjian Wu
Anzhen Hospita Beijing; Fuwai Cardiovascular Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed