REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 28
- 主要终点
- Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)
研究概览
简要总结
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
详细描述
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Ongoing stable GDMT HF management and management of potential comorbidities
- •Age ≥ 40 years old
- •LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
- •Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg
排除标准
- •MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
- •Cardiac Resynchronization Therapy initiated within the past 6 months
- •Severe heart failure
- •Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
- •History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
- •Presence of significant valve disease
- •Known clinically significant untreated carotid artery stenosis
- •Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
结局指标
主要结局
Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)
时间窗: 1 Month Post Implant
The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as: 1. Cardiovascular death through 1-month post implant; 2. Embolic stroke through 1-months post implant; 3. Device and or procedure related adverse cardiac events through 1-month post implant; 4. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min) through 1-month post implant
Change in supine exercise pulmonary capillary wedge pressure (PCWP)
时间窗: 1 Month Post Implant
Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W).
次要结局
- Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF(12 Months)
- Change in Quality Of Life Questionnaire (EQ-5D)(12 Months)
- Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline(1 Month)
- Cardiovascular death(12 Months)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)(12 Months)