NCT05876078已完成不适用
DORAYA-HF EU: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 13
- 主要终点
- Urine Output
研究概览
简要总结
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
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
- •Subject is hospitalized with primary diagnosis of ADHF.
- •N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL.
- •Evidence of fluid overload.
- •Subject insufficiently responds to IV diuretic therapy
排除标准
- •Systolic blood pressure < 80 mmHg at the time of screening.
- •Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
- •Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
- •4. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
- •5. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.
- •6. Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment).
- •7. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
研究组 & 干预措施
ADHF patients
Experimental
ADHF patients with insufficient response to diuretics treated with the Doraya catheter
干预措施: Doraya catheter (Device)
结局指标
主要结局
Urine Output
时间窗: 24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal
Change in total urine output
Serious Adverse Events
时间窗: 30 day post Doraya procedure
Device or procedure related SAEs rate (including MACE) based on MM adjudication.
次要结局
未报告次要终点
研究者
研究点 (13)
Loading locations...
相似试验
已完成
不适用
DORAYA-HF Early Feasibility StudyAcute Decompensated Heart FailureNCT05206422Revamp Medical Inc.21
已完成
不适用
First In Human Study of the Doraya Catheter for the Treatment of AHF PatientsAcute Heart FailureNCT03234647Revamp Medical Ltd.9
招募中
不适用
EFS of the DUO System for Tricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve DiseaseHeart Valve DiseasesTricuspid RegurgitationNCT05913908CroiValve Limited15
已完成
2 期
Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina PectorisRefractory Angina PectorisGene TransferCoronary Artery DiseaseNCT03039751Kuopio University Hospital63
终止
不适用
Evaluation of the Safety and Clinical Performance of the Connected Catheter StudyUrinary RetentionChronicNCT05330598Spinal Singularity26