Evaluating the Safety and Efficacy of Atrial Shunt Implantation Systems for the Treatment of Patients With Chronic Left Heart Failure Prospective, Multicenter, Single-group Target Value Clinical Trials
This trial is a prospective, multicenter, single-group target-value clinical trial in which patients with chronic left heart failure are planned to be recruited. Using the atrial shunt implantation system developed and produced by Morningside (Nantong) Medical Device Co., Ltd., the atrial septum is used to implant the instruments in the atrial septum. to verify the safety and efficacy of the atrial shunt implant system for the treatment of patients with chronic left heart failure.
• Age ≥ 18 years;
• Consistently stable GDMT (Guidelines for Guiding Drugs) according to The Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018 Treatment) heart failure for patients with chronic left heart failure who are still symptomatic for at least 1 month;
• History of hospital admission to heart failure in the past 12 months, serum BNP or NT-proBNP liters within 6 months High (BNP in sinus rhythm patients\> 70 pg/ml, atrial fibrillation patients \> 200 pg/ml, or sinus rhythm patients NT-proBNP\> 200 pg/ml, patients with atrial fibrillation \>600 pg/ml);
• Cardiac catheterization measures resting mean lung capillary wedge pressure PCWP or left atrial pressure LAP≥15 mmHg,And the difference between the RAP order of pulmonary capillary wedge pressure PCWP and right atrial pressure is ≥ 5 mmHg；
• Cardiac Function Classification (NYHA) Grade II-IV;
• The patient or his/her guardian can understand the purpose of the study, voluntarily participate and sign a written informed consent form, which is acceptable Patients followed up； -