A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
研究概览
简要总结
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
详细描述
This is a prospective, randomized, open-label, parallel-controlled, superiority, multicenter clinical study. A total of 208 subjects will be randomized 1:1 after meeting all inclusion/exclusion criteria.
Treatment Group: atrial shunt implantation post-right heart catheterization. Control Group: Right heart catheterization only. Both groups will receive standardized Guideline-Directed Medical Therapy (GDMT) post-procedure. Assessments and follow-ups will be conducted at pre-procedure baseline, day of procedure, 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure.
A Clinical Event Committee (CEC), composed of third-party cardiovascular experts, will independently review and adjudicate primary endpoints in a blinded manner (surgical information concealed).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age ≥ 18 years
- •Diagnosed with HFrEF and receiving Guideline-Directed Medical Therapy (GDMT) for at least 1 month
- •Echocardiographic LVEF between 20% and 40% (20 ≤ LVEF ≤ 40%)
- •Presence of HF-related symptoms and signs, NYHA Class III
- •At least one HF-related hospitalization in the past year or NT-proBNP ≥ 600 pg/mL (sinus rhythm) / ≥ 1000 pg/mL (atrial fibrillation)
- •Invasive hemodynamics: mLAP or mPCWP ≥ 15 mmHg, or left-to-right mean pressure gradient ≥ 5 mmHg
- •Fully understand the study design and follow-up schedule, agrees to participate, and voluntarily signs the Informed Consent Form
排除标准
- •1. End-stage heart failure on the heart transplant waiting list (including meeting LVAD indications)
- •Three consecutive non-invasive systolic blood pressure readings < 90 mmHg
- •Primary structural valvular disease currently indicating surgery or interventional therapy, or severe coronary artery disease requiring revascularization
- •ECG QRS duration ≥ 130 ms with high risk of sudden cardiac death without therapeutic intervention (including meeting CRT/CRT-D indications)
- •Significant right ventricular (RV) dysfunction or severe pulmonary hypertension. Defined by clinical evidence of hepatic congestion, moderate-to-severe edema, or abdominal distension accompanied by poor appetite; significant right atrial or RV enlargement/dysfunction; moderate-to-severe tricuspid regurgitation; mean right atrial pressure > 10 mmHg; systolic pulmonary artery pressure > 60 mmHg; or pulmonary vascular resistance > 3 Wood Units
- •Myocardial infarction or cardiac intervention within the past 1 month
- •Stroke within the past 1 month (excluding lacunar infarction)
- •Decompensated liver cirrhosis (Child-Pugh Class B or worse), or severe chronic pulmonary disease requiring oxygen therapy
- •Anatomical abnormalities precluding procedure completion or making the patient unsuitable for procedure
- •Atrial thrombosis
- •Contraindication to antithrombotic therapy
- •Life expectancy < 1 year
- •Uncontrolled active infection
- •Pregnant, lactating, or women of childbearing potential planning pregnancy in the near future
- •Currently participating in another drug or medical device clinical trial
- •Investigator deems the patient unsuitable for this trial
研究组 & 干预措施
Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
干预措施: D-shant Atrial Shunt (Device)
Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
干预措施: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (Drug)
no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
干预措施: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (Drug)
结局指标
主要结局
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
时间窗: From enrollment to the end of treatment at 12 months
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months. Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or \<24 hours if subject dies in the emergency room). - Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay \<24 hours. - Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
次要结局
- New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome）(From enrollment to the end of treatment at 12 months)
- 6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）(From enrollment to the end of treatment at 12 months)
- Change in NT-proBNP levels(From enrollment to the end of treatment at 12 months)
- Left atrial diameter(From enrollment to the end of treatment at 12 months)
- Device Success Rates (Treatment Group)(From enrollment to the end of treatment at 12 months)
- Changes in 12-lead Electrocardiogram (ECG)(From enrollment to the end of treatment at 12 months)
- Shunt Orifice Patency/Occlusion Status (Treatment Group)(From enrollment to the end of treatment at 12 months)
- All-cause mortality rate(From enrollment to the end of treatment at 12 months)
- Number of HF-related rehospitalizations post-procedure(From enrollment to the end of treatment at 12 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）(From enrollment to the end of treatment at 12 months)
- Right atrial diameter(From enrollment to the end of treatment at 12 months)
- Left ventricular diameter(From enrollment to the end of treatment at 12 months)
- Right ventricular diameter(From enrollment to the end of treatment at 12 months)
- Left Ventricular Ejection Fraction(From enrollment to the end of treatment at 12 months)
- Tricuspid Annular Plane Systolic Excursion(From enrollment to the end of treatment at 12 months)
- Right Ventricular Fractional Area(From enrollment to the end of treatment at 12 months)
- Aortic regurgitation(From enrollment to the end of treatment at 12 months)
- Mitral regurgitation(From enrollment to the end of treatment at 12 months)
- Tricuspid regurgitation(From enrollment to the end of treatment at 12 months)
- Shunt orifice diameter(From enrollment to the end of treatment at 12 months)
- Shunt flow velocity(From enrollment to the end of treatment at 12 months)
- Trans-shunt pressure gradient(From enrollment to the end of treatment at 12 months)
- Shunt flow direction(From enrollment to the end of treatment at 12 months)
- Procedural Success Rates (Treatment Group)(From enrollment to the end of treatment at 12 months)
研究者
Guangyuan Song
Director of interventional center of valvular heart disease
Beijing Anzhen Hospital