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
- 608
- 试验地点
- 141
- 主要终点
- Composite Primary Endpoint
研究概览
简要总结
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
详细描述
Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group.
All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization.
Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Patients will be evaluated at pre-specified time intervals and followed for 5 years.
All patients will be unblinded after the 24 month follow up visit.
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
- •SELECT INCLUSION CRITERIA
- •Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- •Symptoms of HF requiring current treatment with diuretics for ≥ 30 days AND
- •NYHA class II with a 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; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
- •≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; 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.
- •Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose change for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months
- •Age ≥ 40 years old, LV ejection fraction (EF) ≥ 40% within the past 3 months, without previously documented EF <30% (within the past 3 years)
- •Elevated PCWP with a gradient compared to right atrial pressure (RAP), documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mmHg, and greater than RAP by ≥ 5 mmHg
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; AVR (surgical AVR or TAVR) within the past 12 months.
- •Cardiac Resynchronization Therapy initiated within the past 6 months
- •Advanced heart failure defined as one or more of the below:
- •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
- •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 defined by the site cardiologist as:
- •Mitral valve regurgitation defined as grade ≥ 3+ MR
- •Tricuspid valve regurgitation defined as grade ≥ 2+ TR
- •Aortic valve disease defined as ≥ 2+ AR or > moderate AS
- •Known clinically significant untreated carotid artery stenosis likely to require intervention
- •Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
结局指标
主要结局
Composite Primary Endpoint
时间窗: Up to 24 months
The primary endpoint is the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
次要结局
- Change in Kansas City Cardiomyopathy Questionnaire(12 months)
- Change in NYHA Class(12 months)
- Rate of heart failure admissions(Up to 24 months)
- Composite safety endpoint defined as follows:(12 months)