NCT07810335尚未招募不适用
An Evaluation of the FLOWMod System to Occlude Vena Cava Blood Flow in Subjects With Acute Decompensated Heart Failure
FlowMod, Inc.4 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2026年9月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
研究概览
简要总结
FLOW-HF will assess the impact of intermittent partial occlusion of the SVC and/or IVC, the cardiac filling pressure and the difference of effects between the two occlusion locations (SVC and IVC) using the FlowMod flow modulating device on select parameters in subjects experiencing ADHF (Acute Decompensated Heart Failure)
详细描述
Intermittent occlusion of the superior vena cava (SVC) and/or inferior vena cava (IVC) might be associated with positive beneficial effects on cardiac filling pressures and improved patient outcomes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females between 18 and 85 years of age
- •NYHA Class III-IV heart failure
- •Stage C-D systolic heart failure
- •Clinically indicated for right heart catheterization
- •Volume overload status of the subject confirmed by the presence of at least 1 or more of the following congestion signs or symptoms assessed by physical examination or x-ray: Peripheral edema, rales, jugular venous distension, abdominal distension or evidence of congestion by chest x-ray
- •Subjects with RAP >10 mmHg
- •Subjects with PCWP >18 mmHg
- •Subjects with inadequate diuresis defined as total urinary output over the most recent 8 hours prior to enrollment of <1200 mL while on a stable dose of diuretics
- •Subjects with eGFR >30mL/min/1.732
排除标准
- •Severe valvular stenosis
- •Severe aortic valve regurgitation
- •Subjects with a contraindication to contrast dye
- •Active myocardial ischemia (MI) or acute coronary syndrome (ACS)
- •ACS or MI within 30 days prior to enrollment
- •Contraindication to unfractionated heparin
- •Unable to provide informed consent
- •Subjects with impaired decision-making capacity
- •Subjects receiving mechanical circulatory support
- •Subjects with history of cardiac transplant
- •Pregnant subjects
- •Right atrial/ventricular thrombus
- •Subjects with inadequate jugular vein access due to prior jugular vein thrombosis or indwelling chronic ports or catheters or presence of vena cava filter
- •Inability to tolerate right heart catheterization
- •Subjects who have a history of major or minor stroke or TIA ≤ 12 months or subjects with a history of stroke > 12 months who have a residual neurological deficit
- •Hypersensitivity or contraindication to latex
- •Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
- •Subjects with history of CABG ≤ 3 months
- •Subjects with pacemaker or defibrillator leads placed through the SVC ≤ 3 months prior to procedure
- •Rapid atrial fibrillation (HR>120 bpm)
- •Systolic blood pressure < 90 mm Hg
- •Inability to interrupt the anticoagulation treatment
- •Subjects with known coagulopathy or any blood disorders
- •Subjects with life expectancy of <30 days or known risk for mortality within 90 days
- •Prior carotid interventions (stenting or endarterectomy)
- •Severe carotid disease
- •History of DVT (<6m or requiring ongoing anticoagulants for either DVT or hypercoagulable state)
- •History of pulmonary embolism
- •SVC/IVC stenosis
- •SVC/IVC diameter not suitable for balloon inflations
- •Subjects receiving hemodialysis or planning to within 30 days
- •Planned LVAD device placement
- •Subject on >2 inotropes or escalating inotropes during pre-enrollment hospitalization
- •Right ventricular failure based on an RA:PCWP ratio of >0.8, PAPi<1.0; or TAPSE<10
- •Subjects with Ejection Fraction (EF) of <15%
研究组 & 干预措施
FlowMod System in subjects with acute decompensated heart failure (ADHF)
Experimental
Participant with acute decompensated heart failure (ADHF) while the FlowMod System reduces preloading of the heart.
干预措施: FlowMod System in subjects with acute decompensated heart failure (ADHF) (Device)
结局指标
主要结局
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure
时间窗: Through 30 days post procedure
Freedom from device- or procedure-related major adverse events (MAEs) through 30 days post procedure defined as: death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke, or prolongation of heart failure-related hospitalization, attributable to the FlowMod device or procedure
次要结局
- Freedom from primary endpoint MAEs(Through 90 days post procedure)
- Acute Technical Success(Immediately after the procedure)
- Time from device removal to hospital discharge(Through index discharge, an average of 24 hours)
- Heart failure-related re-hospitalization rates at 30 and 90 days(30 days and 90 days)
- Re-hospitalization rates (any cause) at 30 and 90 days(30 days and 90 days)
- Urinary spot sodium (3 hours after start of therapy)(3 hours after start of therapy)
- Weight loss(From baseline through study completion, an average of 90 days)
- Time to discharge readiness(From post-procedure to index discharge, an average of 24 hours)
- Index admission hemodialysis or continued renal replacement therapy(Periprocedural hemodialysis, an average of 24 hours)
- Hemodialysis post discharge through 90 days post discharge(Through 90 days after index discharge)
- Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post device removal(Baseline to 12 hours during therapy and post device removal)
- Diuretic efficiency changes from baseline, at 12 hours during therapy and post device removal(At 12 hours and post device removal, an average of 24 hours)
- EQ5D change from baseline at discharge, 30 and 90 days(EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days)
- eGFR change from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first(Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first)
- Cystatin C changes from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first(Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first)
- Right atrial, pulmonary artery, PCWP and cardiac output changes from baseline, at 8 hours during therapy and end of therapy(Baseline, 8 hours during therapy, and end of therapy)
研究者
研究点 (4)
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