NCT06702501招募中不适用
Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure With Preserved Ejection Fraction - The PeriCut Catheter System Early Feasibility Study (REIMAGINE HFpEF)
Heart Failure Solutions, Inc.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of Safety
研究概览
简要总结
The PeriCut early feasibility study will evaluate the safety and feasibility of successfully performing a minimally invasive pericardiotomy in patients with heart failure with preserved ejection fraction using the PeriCut Catheter System.
详细描述
The PeriCut EFS is a non-randomized, open label, multi-site study testing a new minimally invasive pericardiotomy device for the treatment of heart failure with preserved ejection fraction (HFpEF).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 30 years
- •Symptoms of severe dyspnea (NYHA Class III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
- •Ejection fraction of ≥50%, determined on most recent imaging study within the preceding 2 years (730 days), with no change in clinical status, suggesting potential for deterioration in systolic function.
- •Documentation history of at least one of the following:
- •Any previous hospitalization for HF (>30 days prior to enrollment) with radiographic evidence of pulmonary congestion (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) or Elevated NT-proBNP (>300 pg/ml or >600 pg/ml if in atrial fibrillation) or Echocardiographic evidence of diastolic dysfunction/elevated filling pressures manifested by medial E/e' ratio ≥15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure or Historical catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25), prior to consent.
- •Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) during the screening/baseline visit (after consent)
- •Ambulatory with ability to complete 6-minute walk and cardiopulmonary exercise test (not wheelchair / scooter dependent)
排除标准
- •Recent (< 30 days) hospitalization for heart failure
- •Left (> 6 cm) ventricular dilation noted on cardiac imaging study (echocardiography or MRI) within 6 months prior to enrollment.
- •Any hemoglobin (Hgb) < 8.0 g/dl within 30 days prior to enrollment
- •Any GFR < 20 ml/min/1.73 m2 within 30 days prior to enrollment
- •Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease or ischemia that is a primary contributor to symptoms, in the opinion of the Investigator.
- •Myocardial infarction (MI), unstable angina, catheter ablation for atrial fibrillation, biventricular pacing device implant, or percutaneous coronary intervention (PCI) within 90 days prior to enrollment
- •Any prior cardiac surgery
- •Documented stroke, CVA, TIA, deep vein thrombosis, pulmonary emboli, or suspected neurological event within 180 days prior to enrollment
- •Diagnosis of obstructive hypertrophic cardiomyopathy
- •Known infiltrative cardiomyopathy (e.g., amyloid)
- •Known pericardial disease (constriction, pericarditis, tamponade)
- •Known allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the procedure.
- •Active myocarditis
- •Significant congenital anomaly, anatomic, or comorbid medical problem that, in the opinion of the Investigator, would preclude enrollment in the study.
- •Active collagen vascular disease
- •Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions)
- •Acute or chronic severe liver disease, as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment.
- •Untreated severe obstructive sleep apnea (if known)
- •Implantation or planned implantation of any left atrial shunts or implantable devices used to treat heart failure.
- •Terminal illness (other than HF) with expected survival of less than 1 year
- •Enrollment or planned enrollment in another therapeutic clinical trial in the next 6 months.
- •Inability to comply with planned study procedures or follow-up requirements, including cardiac MRI (e.g., claustrophobia or absolute contraindication to MRI)
- •Women who are currently pregnant, plan to become pregnant, or are currently breastfeeding.
- •Intolerance or contraindication to colchicine
结局指标
主要结局
Assessment of Safety
时间窗: 30 day follow up
Characterize the incidence of serious device and procedure related safety events at 30 days post procedure
Assessment of Acute Procedural Success
时间窗: 30 day follow up
Characterize the rate of acute treatment success of the PeriCut Catheter System to complete the pericardiotomy procedure
次要结局
未报告次要终点
研究者
研究点 (2)
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