NCT06851949招募中2 期
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients with Heart Failure
Cardiac Success5 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Device related Serious Adverse Events (SAE)
研究概览
简要总结
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •Left ventricular end diastolic diameter is greater than or equal to 55mm
- •Ejection fraction ≥20% and ≤40%
- •FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)
- •End-systolic Interpapillary muscle distance ≥ 20mm
- •NYHA class II-IVa
- •Cardiomyopathy of ischemic or non-ischemic origins
- •Understands the nature of the study and procedure and able to provide written informed consent
排除标准
- •Any evidence of structural (chordal or leaflet) mitral lesions
- •Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study
- •Prior mitral valve repair or replacement
- •ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study
- •Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study
- •Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).
- •Severe aortic stenosis
- •Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair
- •Known fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
- •ST segment elevation myocardial infarction within 30 days prior to inclusion in this study
- •Congenital heart disease (except PFO, PDA or ASD)
- •Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies
- •Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg/dL or chronic renal replacement therapy
- •Any therapeutic invasive cardiac procedure within 30 days prior to index procedure
- •Any cardiac surgery, within 3 months prior to inclusion in the study
- •Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study
- •Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
- •Body temperature >38°C within 3 days prior to index procedure
- •Bleeding disorders or hypercoagulable state
- •Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
- •Contraindication to anticoagulants or antiplatelet agents
- •Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated
- •Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
- •Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- •Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months
- •Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
研究组 & 干预措施
Vsling
Experimental
Vsling Device implantation
干预措施: Vsling (Device)
结局指标
主要结局
Device related Serious Adverse Events (SAE)
时间窗: 30 Days
Device related Serious Adverse Events (SAE) within 30 days of the procedure: any SAE that has been determined by the safety monitor to be related to the Vsling™ implantation procedure or the Vsling™ device
次要结局
未报告次要终点
研究者
研究点 (5)
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