To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure

Morningside Medical

Status

Enrolling

Conditions

Left Heart Failure

Treatments

Device: Atrial shunt implant system

Study type

Interventional

Funder types

Other

Identifiers

NCT05486000

IN-ATRIAL SEPTAL-2022-01

Details and patient eligibility

About

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.

Full description

This trial will be carried out in a number of clinical trial institutions in China, and a total of 120 subjects are planned to be included, and all subjects are in progress The single group was registered and surgically treated with an atrial shunt implant system and within 7 days of surgery or at the time of discharge, 30 days after surgery Clinical follow-up was carried out at 3 months after surgery, 6 months after surgery, and 12 months after surgery, followed by data collection, evaluation and statistics Analysis and 12 months of phased clinical summary submitted registration application, on this basis, complete 2 years, 3 years of long-term follow-up.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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； -

Exclusion criteria

Primary organic valvular disease and severe coronary artery disease requiring revascularization that are currently indicated for surgical intervention Changes, heart-related diseases indicated for pacemaker implantation treatment;
Pulmonary hypertension (pulmonary vascular resistance PVR>4WoodsUnits);
History of myocardial infarction or heart treatment surgery within three months;
Patients with infective endocarditis or ultrasound findings of thrombosis or vegetations in the heart;
Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
Life expectancy < 12 months;
History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonary embolism in the past 6 months;
Pregnant or lactating women, or persons with family planning in the next year;
Subjects whose judgement of poor compliance and who were unable to complete the study as required; -