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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Left Heart Failure

Intervention / Treatment
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* Device: Atrial shunt implant system


Participation Criteria
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Eligibility Criteria
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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; -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system | Device: Atrial shunt implant system<br>* Patients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the Atrial Shunt Implant System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical treatment success rate was 12 months after operation | Death and heart failure-related rehospitalization were avoided 12 months after surgery | Twelve months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrument success rate | The diverter was successfully implanted, the morphology was normal, and the conveyor system was successfully withdrawn | Intraoperative | 
| Surgical success rate | On the basis of the success of the instrument, ultrasound is seen in simple left-to-right shunting immediately after surgery | Immediately after surgery | 
| 6 minutes walking distance change | The participants were assessed at the appropriate follow-up site | Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery 30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery | 
| New York Cardiac Function Grading NYHA | New York Cardiac Function Grading NYHA is divided into four levels, which are determined according to the clinical presentation of the patient, and the higher the level, the more severe the symptoms of heart failure | Preoperative screening ，30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery | 
| Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes | Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes consisted of a total of 23 items with a score between 0-100, with higher scores indicating less adverse effects of heart failure on a patient's quality of life | Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery | 
| NT-proBNP or BNP variation | Corresponding follow-up sites are obtained by laboratory blood tests | Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year | 
| Probability of postoperative echocardiographic changes | Obtained through instrumentation inspection | During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year | 
| Incidence of device-related serious adverse events | Serious adverse events related to the instrument that occur after the implantation of the instrument, such as the shedding of the instrument, embolism, causing damage to the mitral or tricuspid valve, causing severe arrhythmias, infectious endocarditis, any need to re-operate the instrument to remove the instrument, etc | 30 days after surgery | 
| Serious adverse events and incidence of adverse events | Events that occur during clinical trials that result in death or serious deterioration of health status, as well as the probability of adverse medical events that occur after a subject is treated with a trial product | Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years |