NCT05686317进行中（未招募）不适用
A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
Edwards Lifesciences58 个研究点 分布在 5 个国家目标入组 100 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 58
- 主要终点
- Device + Medical Therapy: Subjects with Early Major Adverse Events
研究概览
简要总结
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
详细描述
The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)
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
- Double (Participant, 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
- •Symptomatic heart failure
- •A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and
- •NYHA class II to ambulatory NYHA class IV (IVa), and
- •Documentation of at least one of the following from the date of initial informed consent or date of enrollment:
- •i. Within the prior 12 months, EITHER:
- •HF hospital admission (with HF as the primary or secondary diagnosis)
- •Treatment with intravenous (IV) or intensification of oral diuretics for HF
- •ii. Within the prior 6 months, EITHER:
- •BNP value > 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation (AF)
- •BNP > 125 pg/ml for permanent or long-term persistent AF
- •NT-proBNP > 125 pg/ml in NSR or paroxysmal AF
- •NT-proBNP > 375 pg/ml for permanent or long-term persistent AF d. There is objective evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core lab as: As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at ≥ 20 Watts exercise (PCWP ≥ 20W) is elevated to ≥ 25 mmHg and exceeds [the corresponding] right atrial pressure (RAP) by ≥ 8 mmHg • In the judgment of the treating physician and the Central Screening Committee the patient is on GDMT for HFpEF/HFmrEF for >30 days prior to screening and baseline assessments, that is expected to be maintained without change for 6 months.
排除标准
- •Severe heart failure defined as one or more of the below:
- •ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF
- •If Body Mass Index (BMI) < 30, cardiac index < 2.0 L/min/m2
- •If BMI ≥ 30, cardiac index < 1.8 L/min/m2
- •Inotropic infusion (continuous or intermittent) within the past 6 months
- •Patient is on the cardiac transplant waiting list
- •Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to > 40%
- •Valve disease:
- •Degenerative mitral regurgitation > moderate
- •Functional or secondary mitral valve regurgitation defined as grade > moderate
- •Mitral stenosis > mild
- •Primary or secondary tricuspid valve regurgitation defined as grade > moderate
- •Aortic valve disease defined as aortic regurgitation grade > moderate or aortic stenosis > moderate
- •More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters:
- •Tricuspid annular plane systolic excursion (TAPSE) <1.4 cm, or
- •RV size ≥ LV size
- •Right ventricular ejection fraction (RVEF) < 35%; or
- •Imaging or clinical evidence of congestive hepatopathy
- •Mean right atrial pressure (mRAP) > 15 mmHg at rest
- •Pulmonary vascular resistance (PVR) ≥ 5.0 WU
- •Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular cardiovascular procedure within past 3 months or current indication for coronary revascularization
- •Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months
- •Renal insufficiency as determined by creatinine (sCr) level > 2.5 mg/dL or estimated glomerular filtration rate (eGFR) < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
- •Performance of the six-minute walk test (6MWT) with a distance < 50m OR > 450m
- •Active endocarditis or infection requiring intravenous antibiotics within 3 months
研究组 & 干预措施
APTURE shunt + medical therapy
Experimental
干预措施: Edwards APTURE transcatheter shunt system (Device)
Sham + medical therapy
Sham Comparator
干预措施: Sham procedure (Diagnostic Test)
结局指标
主要结局
Device + Medical Therapy: Subjects with Early Major Adverse Events
时间窗: 30 days
Shunt implant safety: proportion of patients in the APTURE shunt group without any serious device or procedure-related (CEC adjudicated) complications (i.e., Major Adverse Cardiovascular, Cerebrovascular, and Renal Events \[MACCRE\]; at 30 days post index procedure or hospital discharge, whichever is later.
Mean change in PCWL from baseline at 6 months
时间窗: 6-months
Hemodynamic Effectiveness: change in pulmonary capillary wedge during load (PCWL, mmHg/W/kg) from baseline at 6 months.
次要结局
- KCCQ-OSS change from baseline at 6-month follow-up(6-months)
- Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (≥) a 15-point improvement from baseline KCCQ-OSS or at least (≥) a 25m improvement from baseline 6MWT.(6-months)
- 6MWT change from baseline at 6-month follow-up(6-months)
研究者
研究点 (58)
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