NCT05501652已完成1 期
Evaluation of the Safety and Efficacy of a Percutaneously Created Interatrial Shunt in Patients With Chronic Heart Failure Without Pulmonary Vascular Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF 25-39%), or mid-range left ventricular ejection fraction (HFmrEF, EF 40-49%), or preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%), with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.
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
- •NYHA class II if a prior history of > NYHA class II; OR NYHA class III; OR ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit.
- •Within 12 months of study entry: ≥ 1 HF hospital admission (with HF as the primary or secondary diagnosis); OR treatment with IV diuretics; OR an NT-pro BNP value > 150 pg/ml in normal sinus rhythm, > 450 pg/ml in atrial fibrillation, or a BNP value > 50 pg/ml in normal sinus rhythm, > 150 pg/ml in atrial fibrillation within the past 6 months.
- •Site determined echocardiographic LVEF > 25% as measured by the study specific screening transthoracic echo.
- •Site determined hemodynamic criteria assessed by the screening supine bicycle exercise right heart catheterization test, including each of the components (a)-(b) below:
- •a. At rest: i. RAP < 14 mmHg ii. PVR < 3.5 Wood units iii. PAS < 70 mmHg iv. Cardiac Index > 1.9 L/min b. At exercise (25-watts): i. PCWP must have a gradient > 5 mmHg of the RA ii. End-expiratory PCWP ≥ 25 mmHg iii. PVR < 1.8 Wood units [if PVR cannot be obtained (e.g., patient stopped pedaling), TPG < 12 mmHg]
排除标准
- •Presence of advanced heart failure documented in the medical history, defined as one or more of the following:
- •ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- •Cardiac index < 2.0 L/min/m2
- •Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
- •Patient is on the cardiac transplant waiting list.
- •Presence of uncorrected valve disease documented in the medical history and/or confirmed by the study-specific TTE protocol performed during screening, defined as one or more of the following:
- •Greater than moderate mitral regurgitation
- •Greater than moderate mitral stenosis
- •Greater than mild tricuspid regurgitation
- •Greater than moderate aortic stenosis
- •Greater than moderate aortic regurgitation
- •Presence of clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention.
- •Presence of clinically significant un-revascularized coronary artery disease documented in the medical history that is likely to require intervention, defined as epicardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
- •Presence of hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy such as hemochromatosis or sarcoidosis.
- •Presence of uncontrolled tachyarrhythmia documented in the medical history.
- •Medical history of one or more of the following cardiac procedures:
- •MI and/or percutaneous coronary intervention (PCI) within the past 3 months
- •CABG within the past 3 months
- •SAVR or TAVR within the past 6 months
- •MVR or TMVR within the past 6 months
- •Medical history of any implanted pacemaker device.
- •Medical history of cardiac ablation procedure (either for atrial or ventricular arrhythmias) within the past 3 months.
- •Presence of chronic pulmonary disease documented in the medical history, defined by one or more of the following:
- •Current requirement for continuous home oxygen use
- •Hospitalization within the past 12 months for treatment of chronic pulmonary disease
- •Significant chronic pulmonary disease defined as FEV1 < 50% of predicted
- •If COPD is documented in the medical history and the patient is taking oral or inhaled COPD medication at the time of screening, then a spirometry test is to be performed and patient excluded if FEV1 < 50%.
- •Presence of pulmonary hypertension with PASP ≥ 70 mmHg OR PVR > 3.5 Wood units at rest, documented in the medical history or diagnosed during the initial right heart catheterization.
结局指标
主要结局
Primary Safety Endpoint
时间窗: 1-Month
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
Primary Efficacy Endpoint
时间窗: 1-Month
Change in supine exercise PCWP at 25-watts exercise from baseline to Month 1.
次要结局
未报告次要终点
研究者
研究点 (1)
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