NCT06072937尚未招募不适用
Clinical Evaluation of HeartPoint Global Intellistent for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy
HeartPoint Global0 个研究点目标入组 10 人开始时间: 2024年6月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Change in pulmonary vascular resistance (PVR)
研究概览
简要总结
IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in pediatric, adolescent and adult patients with congenital heart disease associated pulmonary arterial hypertension or left ventricular dilated cardiomyopathy.
详细描述
IntelliStent Implant System is a kit of stents for adjustable interventional reduction of blood flow through a novel and minimally invasive intervention to replace surgical Pulmonary Artery Banding (PAB).
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adolescent (12-17 years) or Adult (age >18 years)
- •Uncorrected CHD (ASD, VSD, PDA, AVSD) with left to right + systemic pulmonary artery pressure or mixed shunting regardless if pulmonary vascular resistance is modifiable or fixed
- •Diagnosed with WHO Group 1 PH Classification pulmonary hypertension associated with congenital heart disease, evidence by the following parameters measured at rest:
- •Mean pulmonary artery pressure (mPAP) ≥ 50 mmHg
- •Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP)
- •Pulmonary vascular resistance > 3 Wood Units
- •Patients with left ventricular dilated cardiomyopathy with symptoms despite optimal medical therapy
- •Current WHO Functional Class III or IV.
- •Patients with the following anatomical dimensions (gated CT with angio or MRI with EKG) at target implantation site:
- •MPA diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm, or
- •Left and Right PA Branch diameter @ systolic ≥ 15 mm and ≤ 24 mm and length @ systolic ≥ 28 mm
- •Main pulmonary artery (MPA) or left/right PA Branch anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by computed tomography (CT), fluoroscopy or echocardiography.
- •Each patient, or his or her guardian or legal representative, is willing to give informed consent, subject to national law.
排除标准
- •Right ventricular dysfunction
- •Severe AV valve regurgitation of the pulmonary ventricle
- •Complex CHD
- •Ongoing infection
- •Patients where definitive correction of the CHD is indicated and available as a possible treatment option
- •Patients with pressure gradient across the systemic outflow tract/subaortic region >40 mmHg @ rest
- •PAH-CHD patients with small defects that may be incidental findings
- •PAH after corrective cardiac surgery
- •Anatomical limitation to IntelliStent® (e.g. pulmonary artery size)
- •Known or suspected thrombosis of the femoral or iliac veins on the proposed site of venous cannulation
- •Vasculature lesions or characteristics that prevent percutaneous transluminal catheterization
- •Allergies or contraindications to prescribed procedural medications and contrast medium Anomalous pulmonary venous return (total or partial)
- •Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
- •Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel
- •Pregnant, lactating or planning pregnancy
结局指标
主要结局
Change in pulmonary vascular resistance (PVR)
时间窗: 24 Weeks
The primary efficacy endpoint is a binary variable. For patients with a baseline pulmonary vascular resistance (PVR) \>1000 dynes·s·cm-5, success is defined by an absolute reduction in PVR of ≥300 dynes·s·cm-5 at 24 weeks. For patients with a baseline PVR ≤1000 dynes·s·cm-5, success is a 30% reduction in PVR at 24 weeks.
次要结局
- Change From Baseline to Week 12 in Left Ventricular Volumes(Baseline to 12 Weeks)
- Six Minute Walk Test Distance(12 Weeks)
- Change From Baseline of the Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline to 12 Weeks)
- NYHA Class change from Baseline at Week 12(Baseline to 12 weeks)
- Change From Baseline to Week 12 in Borg Dyspnea Score(Baseline to 12 weeks)
- Change From Baseline to Week 12 in Ejection Fraction(Baseline to 12 Weeks)
研究者
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