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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The clinical treatment success rate was 12 months after operation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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； -
排除标准
- •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; -
研究组 & 干预措施
treatment group
This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system
干预措施: Atrial shunt implant system (Device)
结局指标
主要结局
The clinical treatment success rate was 12 months after operation
时间窗: Twelve months after surgery
Death and heart failure-related rehospitalization were avoided 12 months after surgery
次要结局
- Surgical success rate(Immediately after surgery)
- Instrument success rate(Intraoperative)
- NT-proBNP or BNP variation(Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year)
- Incidence of device-related serious adverse events(30 days after surgery)
- 6 minutes walking distance change(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(Preoperative screening ，30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery)
- Probability of postoperative echocardiographic changes(During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year)
- Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes(Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery)
- Serious adverse events and incidence of adverse events(Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years)