Heart Failure
Conditions
Interventions
Experimental group:Atrial shunt device implatation
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The subjects should meet all the following conditions: Over 18 years old; The subjects fully understood the nature of the study, complied with the trial requirements, and agreed to conduct all follow-up inquiry tests and examinations Check; The subjects were diagnosed with heart failure with decreased ejection fraction (left ventricular ejection fraction measured by echocardiography)= 1000 pg / ml in sinus rhythm; Atrial fibrillation >= 1600 pg / ml; Or brain natriuretic peptide (BNP): 300 pg / ml or more in sinus rhythm; Atrial fibrillation >= 500 pg / ml; The results of invasive hemodynamic measurement should meet at least one of the following requirements: 1 mlap (or mpcwp) >= 15 mmHg at rest; The pressure gradient between 2mlap (or mpcwp) and MRAP was >= 5mmhg; The pressure step difference between 3slap (or spcwp) and SRAP was more than or equal to 10mmhg.
Exclusion criteria
Exclusion criteria: Patients should not meet any of the following conditions: The vital signs were unstable or arrhythmias were not controlled (blood pressure 130 BPM or 25 beats / min); At present, there are indications for surgical intervention in primary organic valve disease or severe coronary artery disease requiring revascularization; Patients with high risk factors of sudden death and without treatment intervention (high risk factors of sudden death refer to those who meet one or more of the following criteria: complete left bundle branch block, uncontrolled repeated ventricular tachycardia, left ventricular outflow tract obstruction, history of arrhythmia related syncope, family history of sudden death, history of cardiac arrest, etc.); / / significant right ventricular dysfunction or severe pulmonary hypertension (meeting one or more of the following criteria: significant history of liver congestion or repeated moderate or above cardiogenic edema, right ventricular diameter measured by ultrasound > left ventricle, mean right atrial pressure measured by catheter > 12mmhg, pulmonary artery systolic pressure measured by catheter > 70mmhg); History of myocardial infarction or cardiac surgery within 1 month; History of stroke within 1 month (excluding lacunar infarction); Patients with decompensated liver cirrhosis (child Pugh grade B or above), renal failure (CKD stage III or above), or severe chronic lung disease with respiratory failure; The operation cannot be completed or anatomically unsuitable due to the abnormal anatomy; Atrial thrombosis; There are contraindications for antithrombotic therapy; The life expectancy is less than 1 year; An uncontrolled active infection; During pregnancy or lactation, women of childbearing age plan to be pregnant in the near future; The researcher thinks that the compliance is poor and can't cooperate with the follow-up visit; Currently participating in clinical trials of other drugs or medical devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality;Heart failure related readmission; | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA change;NT-proBNP;Echocardiography index;6 minute walk distance; | — |
Countries
China
Contacts
Public ContactNianguo Dong
Union Hospital Affiliated to Tongji Medical College, Huazhong University of science and technology
Outcome results
None listed