chronic heart failure
Conditions
Interventions
Treatment group:Implantation of atrial shunt after right heart catheterization+ medical treatment
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age 18 or above; (2) The subject was diagnosed with heart failure with reduced ejection fraction and has been receiving standardized drug therapy (GDMT) guided by guidelines for at least one month. (3) Cardiac ultrasound measurement of left ventricular ejection fraction: 20 = LVEF = 40%. (4) The subject presented with symptoms and signs related to heart failure, according to the New York Heart Association (NYHA) functional class III. (5) At least one hospitalization history related to heart failure or N-terminal pro brain natriuretic peptide (NT proBNP) level =600 pg/mL within the past year. (6) The results of invasive hemodynamic measurements meet the following criteria: mean left atrial pressure or pulmonary artery wedge pressure =15mmHg or mean left to right pressure gradient =5mmHg. (7) The patient fully understands the nature of the study and follow-up arrangements, agrees to participate in this study, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) End stage heart failure has entered the waiting list for heart transplantation. (2) Three consecutive non-invasive blood pressure and systolic blood pressure10mmHg, pulmonary artery systolic pressure>60mmHg, PVR>3wood. U. (6) History of myocardial infarction or cardiac treatment surgery within one month. (7) History of stroke within one month (excluding lacunar infarction). (8) Decompensated cirrhosis (stage B or above) and severe chronic lung diseases that rely on oxygen therapy. (9) Anatomical abnormalities make surgery impossible or anatomically unsuitable for surgery. (10) Thrombosis formation in the atrium. (11) There are contraindications for antithrombotic therapy. (12) The expected lifespan is less than one year. (13) Uncontrolled active infections. (14) Pregnant or breastfeeding women of childbearing age who plan to become pregnant in the near future. (15) Currently participating in clinical trials of other drugs or medical devices. (16) The researchers believe that patients who are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause death;Heart transplantation or left heart assist device implantation caused by heart failure;Postoperative readmission for heart failure treatment;Outpatient examination shows worsening of heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative changes in exercise tolerance: 6-minute walking test;New York Heart Association Classification of Cardiac Function;NT proBNP changes;Success rate of instruments and surgery; | — |
Countries
China
Contacts
Public ContactSong guangyuan
Beijing Anzhen Hospital
Outcome results
None listed