NCT05425459进行中（未招募）不适用
Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure (Protocol #2201)
Corvia Medical61 个研究点 分布在 6 个国家目标入组 750 人开始时间: 2022年11月17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
- 750
- 试验地点
- 61
- 主要终点
- Composite Primary Endpoint
研究概览
简要总结
Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
详细描述
Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath.
Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt 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
- •Chronic symptomatic heart failure (HF) documented by the following:
- •Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND
- •New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND
- •≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-proB-type Natriuretic Peptide (NT-pro BNP) value > 150 pg/ml in normal sinus rhythm, > 450 pg/ml in atrial fibrillation, or a brain natriuretic peptide (BNP) value > 50 pg/ml in normal sinus rhythm, > 150 pg/ml in atrial fibrillation within the past 6 months
- •Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics
- •Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction < 30% in the 5 years prior.
- •Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
- •Left Atrial (LA) diameter > 4 cm; or
- •Diastolic LA volume > 50 or LA volume index > 28 ml/m2 or
- •Lateral e' < 10 cm/s; or
- •e' < 8 cm/s; or
- •Site determined elevated pulmonary capillary wedge pressure (PCWP) with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25 millimeters of mercury (mm Hg), and greater than RAP by ≥ 5 mm Hg.
- •Resting RAP ≤ 14 mmHg
- •Site determined hemodynamic evidence of peak exercise pulmonary vascular resistance (PVR) < 1.75 Wood units
- •Age ≥ 40 years old
- •Participant has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the Institutional Review Board (IRB) or Ethics Committee (EC)
- •Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
- •Transseptal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator.
排除标准
- •Advanced heart failure defined as one or more of the below:
- •ACC/AHA/European Society of Cardiology (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 meters), OR 6-minute walk test > 600m
- •The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain)
- •Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following:
- •More than mild right ventricular (RV) dysfunction as estimated by transthoracic echocardiogram (TTE); OR
- •TAPSE < 1.4 cm; OR
- •Right ventricular (RV) size ≥ left ventricular (LV) size as estimated by TTE; OR
- •Ultrasound or clinical evidence of congestive hepatopathy; OR
- •Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%.
- •Any implanted cardiac rhythm device
- •Structural heart repair aortic valve replacement (AVR) or mitral valve replacement (MVR) (surgical or percutaneous) within the past 12 months; planned valve intervention in the next 3 months, or presence of hemodynamically significant valve disease as assessed by the site cardiologist and defined as:
- •Mitral valve disease grade ≥ 3+ mitral regurgitation (MR) or > mild Mitral Stenosis (MS); OR
- •Tricuspid valve (TR) regurgitation grade ≥ 2+ TR; OR
- •Aortic valve disease ≥ 2+ aortic regurgitation (AR) or > moderate aortic stenosis (AS)
- •Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- •Participants with existing or surgically closed (with a patch) atrial septal defects. Participants with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded
- •Myocardial Infarction (MI) and/or percutaneous cardiac intervention within past 3 months; Coronary Artery Bypass Graft (CABG) surgery in past 3 months or any planned cardiac interventions in the 3 months following enrollment.
- •Known clinically significant un-revascularized coronary artery disease, defined as: coronary artery stenosis with angina or other evidence of ongoing active coronary ischemia
- •Known clinically significant untreated carotid artery stenosis likely to require intervention
- •Atrial fibrillation with resting heart rate (HR) > 100 beats-per-minute (BPM)
- •Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
- •History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
- •Participant is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy
- •Anemia with Hemoglobin < 10 g/dl
- •Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as forced expiratory volume (FEV)1 <1Liter
- •Resting arterial oxygen saturation < 95% on room air, <93% when residing at high altitude
- •Currently requiring dialysis; or estimated glomerular filtration rate eGFR < 25ml/min/1.73 m2 by chronic kidney disease (CKD) CKD-Epi equation
- •Systolic blood pressure > 170 mm Hg at screening
- •Significant hepatic impairment defined as 3 times upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
- •Participants on significant immunosuppressive treatment or on systemic steroid treatment
- •Life expectancy less than 12 months for known non-cardiovascular reasons
- •Known hypersensitivity to nickel or titanium
- •Women of childbearing potential
- •Severe obstructive sleep apnea not treated with continuous positive airway pressure (CPAP) or other measures
- •Body Mass Index (BMI) > 45; BMI 40 - 45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely
- •Severe depression and/or anxiety
- •Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
- •In the opinion of the investigator, the Participant is not an appropriate candidate for the study.
研究组 & 干预措施
Treatment
Experimental
Participants randomized to the treatment arm will undergo a fluoroscopic and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and InterAtrial Shunt Device (IASD) System II implant procedure.
干预措施: Corvia Atrial Shunt System / IASD System II (Device)
Control
Sham Comparator
Participants randomized to the control arm will undergo fluoroscopy and intracardiac echocardiography from the femoral vein or transesophageal echocardiography, for examination of the atrial septum and left atrial appendage.
干预措施: Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) (Other)
结局指标
主要结局
Composite Primary Endpoint
时间窗: Up to 12 months
The primary endpoint is a composite of heart failure event rates and Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health.
次要结局
- The rate of new onset or worsening of kidney dysfunction(Through 12 months)
- The incidence of thrombo-embolic complications including transient ischaemic attack (TIA) and systemic embolization)(Through 12 months)
- The rate of major adverse cardiac periprocedural events(Through 30 days)
- The incidence of non-fatal, ischemic stroke(Through 12 months)
- The incidence of newly acquired persistent or permanent atrial fibrillation (AF) or atrial flutter(Through 12 months)
- The incidence of participants with a ≥30% decrease in Tricuspid Annular Plane Systolic Excursion (TAPSE)(Through 12 months)
- The incidence of cardiovascular mortality(Up to 12 months)
- The rate of time-to-cardiovascular mortality(Up to 12 months)
- The change in New York Heart Association (NYHA) Class(12 months)
- The rate of heart failure (HF) admissions(Through 24 months)
- The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score(12 months)
研究者
研究点 (61)
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