NCT05001711已完成不适用
Acute Feasibility Study Assessing Safety and Performance of Aria CV Acute PH System in Patients With WHO Group 2 and 3 Pulmonary Hypertension
Aria CV, Inc1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.
详细描述
This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.
The planned enrollment is a maximum enrollment of 40 patients to ensure up to 10 "Device Deployed" subjects in each arm at one site.
The duration of study participation for each subject is expected to be approximately 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •for WHO Group 2
- •18 years or older
- •Symptomatic WHO Functional Class (FC) III
- •Based on preexisting echocardiography within the past 6 months, evidence of right heart dysfunction: RV ejection fraction (RVEF) < 45% by visual estimate, and at least one of the following:
- •Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm
- •RV Fractional area change <35%
- •RVs' velocity < 10 cm/s
- •RV free wall strain <18%
- •RVEF < 35% by visual estimate
- •MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months.
- •Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg
- •Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP > 30 mmHg
- •Patient is willing and able to provide informed consent.
- •Previous diagnosis of left heart dysfunction.
- •Intra-procedural confirmation of WHO Group 2 diagnosis based on resting RHC:
- •PAWP: >15 and ≤30 mmHg, and
- •Combined post- and pre-capillary pulmonary hypertension (CpcPH), defined as PVR > 3 WU
排除标准
- •for WHO Group 2
- •Anatomy not suitable for RHC
- •Anatomy not suitable for placement of Aria CV Acute Device:
- •Contraindication to 16 Fr femoral vein access
- •Body habitus that would preclude safe placement of any components of Aria CV Acute Device
- •Any previous tricuspid valvular surgery, percutaneous valve repair, or presence of prosthetic cardiac device such as pacemaker or defibrillator leads, or vena cava filter that in the opinion of the investigator may interfere with investigational device placement or performance
- •Uncontrolled atrial fibrillation
- •Sustained tachyarrhythmia (heart rate >110/min) at time of index procedure
- •Right heart valve regurgitation:
- •Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation
- •Severe (Grade 4) tricuspid valve regurgitation
- •Patient with any of the following medical history or comorbidities:
- •History of unprovoked Pulmonary Embolism or CTEPH
- •Currently on dialysis
- •Current or recent (<6 months prior to planned index procedure) endocarditis
- •Clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt
- •Current active systemic infection requiring antibiotic therapy
- •As determined by the physician the subject is medically unstable and/or represents an unreasonable procedural risk.
- •Hypersensitivity or contraindication to
- •Required medications (e.g. contrast agents, heparin) which cannot be adequately managed, or
- •Materials in investigational device including polyurethane, silicone, nickel, and titanium
- •Pregnant or lactating woman
- •Currently participating in other investigational drug or device trials that may interfere with the outcome of this study
- •Diagnosis of WHO Groups 1, 3, 4 or 5 PH
- •Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy-HOCM)
- •Untreated aortic or mitral stenosis
- •Inclusion Criteria for WHO Group 3
- •18 years or older
- •Symptomatic WHO Functional Class (FC) III
- •Based on preexisting echocardiography within the past 6 months, evidence of right heart dysfunction: RV ejection fraction (RVEF) < 45% by visual estimate, and at least one of the following:
- •Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm
- •RV Fractional area change <35%
- •RVs' velocity < 10 cm/s
- •RV free wall strain <18%
- •RVEF < 35% by visual estimate
- •MPA diameter > 32mm and length >70 mm as determined by preexisting fluoroscopy, echocardiography, computerized tomography, or magnetic resonance imaging within the past 6 months
- •Elevated pulmonary arterial pressure based on preexisting resting RHC within the past 6 months: Mean PAP (mPAP) > 30 mmHg
- •Intra-procedural confirmation of elevated pulmonary arterial pressure based on resting RHC: mPAP > 30 mmHg
- •Patient is willing and able to provide informed consent
- •Previous diagnosis of chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis
- •Intra-procedural confirmation of WHO Group 3 diagnosis based on resting RHC:
- •PAWP≤ 15 mmHg, and
- •PVR > 4 WU
- •Exclusion Criteria for WHO Group 3
- •Anatomy not suitable for RHC
- •Anatomy not suitable for placement of Aria CV Acute Device:
- •Contraindication to 16 Fr femoral vein access
- •Body habitus that would preclude safe placement of any components of Aria CV Acute device
- •Any previous tricuspid valvular surgery, percutaneous valve repair, or presence of prosthetic cardiac device such as pacemaker or defibrillator leads, or vena cava filter that in the opinion of the investigator may interfere with investigational device placement or performance
- •Uncontrolled atrial fibrillation
- 另有 17 项未显示
结局指标
主要结局
Primary Safety Endpoint
时间窗: 30 Days
Incidence of investigational device-related serious adverse events (SAEs) through 30 days post-index procedure, based on Clinical Events Committee assessment.
次要结局
- Secondary Safety Endpoint(30 Days)
研究者
研究点 (1)
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