NCT05375110Unknown不适用
A Prospective, Multi-center and Objective Performance Criteria Study to Evaluate the Effectiveness and Safety of NoYA™ Radiofrequency Interatrial Shunt System for the Treatment of Chronic Heart Failure With Elevated Left Atrial Pressure
Hangzhou NOYA MedTech Co. Ltm.31 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 31
- 主要终点
- Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
研究概览
简要总结
A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd. for the Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.
详细描述
This is a prospective, multi-center and objective performance criteria study to evaluate the effectiveness and safety of the NoYA™ Radiofrequency Interatrial Shunt System for the treatment of chronic heart failure with elevated left atrial pressure. Patients with chronic heart failure with elevated left atrial pressure who meet study eligibility criteria will be enrolled and undergo radiofrequency ablation of the interatrial procedure with NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech) after signing the informed consent. The follow-up will be conducted at discharge, 1 month, 3 months, 6 months, and 12 months after the operation.
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
- 否
入选标准
- •Age≥18 years old.
- •Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- •New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
- •One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify).
- •Sustained and stable GDMT (guideline-directed medical therapy) for heart failure according to the 2017 ACC/AHA/HFSA guidelines management as well as potential complications of heart failure management, heart failure symptoms remain uncontrolled.
- •LV ejection fraction (EF) ≥15% measured by echocardiography in the last 6 months.
- •Invasive hemodynamic measurements showed mLAP or end-expiratory resting PCWP≥15mmHg, and mLAP or PCWP-RAP ≥5mmHg.
- •Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, as approved by the IRB.
排除标准
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- •Bacterial endocarditis.
- •6-minute walk test distance <100m or > 450m.
- •History of atrial septum implantation (e.g. atrial septum occlusion, patent foramen ovale occlusion) or inferior vena cava filter.
- •History of myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) within the past 3 months; Untreated severe coronary artery stenosis which requires revascularization.
- •History of cardiac resynchronization therapy (CRT/CRT-D) or implantable cardioverter-defibrillator (ICD) implantation within the past 6 months.
- •Right heart failure
- •Pulmonary arterial hypertension (TTE or cardiac catheterization shows pulmonary artery systolic pressure>70mmHg)
- •Life expectancy less than 12 months.
- •In the opinion of the investigator, the subject is not an appropriate candidate for the study.
结局指标
主要结局
Rate of free from death and heart failure (HF) related hospitalizations at 12 months follow-up
时间窗: 12 months after the procedure
1. Death: Cardiac death 2. Hospitalization：HF-related Hospitalizations
次要结局
- Acute device success(Immediately post-procedure)
- Acute procedural success(Immediately post-procedure)
- Change in 6-Minute Walk Test(Baseline, 6 months, 12 months after procedure)
- Change in Nt-pro BNP(Preoperative, 1 month, 3 months, 6 months, 12 months after procedure)
- Change in PCWP or Mean Left Atrial Pressure(Before, immediately after procedure)
- Left-to-right Atrial Blood Shunt Evaluation(6 months, 12 months after procedure)
- Change in NYHA Class(Preoperative, 1 month, 3 months, 6 months, 12 months after procedure)
- Change in Minnesota Living with Heart Failure Questionnaire(Preoperative, 1 month, 3 months, 6 months, 12 months after procedure)
- Rate of re-admission, re-operation/intervention for heart failure(12 months after procedure)
研究者
研究点 (31)
Loading locations...
相似试验
已完成
不适用
MatErnal BLood IS Source to Accurately Diagnose Fetal AneuploidyPregnant WomenPrenatal CareNCT01122524Verinata Health, Inc.10,000
已完成
不适用
Multicenter, prospective evaluation of performance, safety, and surveillance of the WiCS-LV System in patients indicated for Cardiac Resynchronization TherapyWireless Stimulation Endocardially for Cardiac Resynchronization Therapy10007521NL-OMON34226EBR Systems Inc.20
招募中
不适用
To assess the efficacy (survivorship) of the Quadra-P Hydroxyapatite coated femoral stem in patients undergoing a primary total hip replacement surgery.Hip OsteoathritisMusculoskeletal - OsteoarthritisACTRN12620000441910Medacta Australia Pty Ltd300
已完成
2 期
Inhaled Nitric Oxide for Patients With MABSCMycobacterium Abscessus InfectionNCT03208764Beyond Air Inc.9
招募中
不适用
Multicentre SMS Study - FRDysplasia of Hip JointTraumatic Arthritis of HipAvascular Necrosis of Femur HeadHip OsteoarthritisNCT06640764Medacta International SA260