NCT01913613已完成不适用
REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Corvia Medical28 个研究点 分布在 11 个国家目标入组 64 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 28
- 主要终点
- MACCE
研究概览
简要总结
The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
- •Age ≥ 40 years old
- •Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
- •Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
- •PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
- •PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg
排除标准
- •3. Severe heart failure defined as:
- •ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
- •Fick Cardiac Index < 2.0 L/min/m2
- •Requiring inotropic infusion (continuous or intermittent) within the past 6 months
- •Patient is on the cardiac transplant waiting list
- •Inability to perform 6 Minute Walk Test
- •Known significant coronary artery disease (stenosis >70%)
- •History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
- •Known severe carotid artery stenosis (> 70%)
- •Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
结局指标
主要结局
MACCE
时间窗: 6 months
subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism)
次要结局
未报告次要终点
研究者
研究点 (28)
Loading locations...
相似试验
已完成
2 期
A Phase II Study to Evaluate the Efficacy of IdeS to Desensitize Transplant Patients With a Positive Crossmatch TestKidney Failure, ChronicNCT02790437Hansa Biopharma AB19
进行中（未招募）
1 期
A Study Evaluating the Safety and Efficacy of EDIT-301 in Participants With Severe Sickle Cell Disease (RUBY)Sickle Cell DiseaseHemoglobinopathiesNCT04853576Editas Medicine, Inc.45
进行中（未招募）
不适用
REDUCE LAP-HFREF TRIALHeart FailureNCT03093961Corvia Medical10
已完成
不适用
Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic ImagesDiabetic Retinopathy, DRDiabetic MellitusNCT06241664AEYE Health Inc601
终止
不适用
A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic StrokeStroke, AcuteNCT03957278MIVI Neuroscience, Inc.4