NCT02305602已完成1 期
A Phase I, Open-label Study of the Effects of Percutaneous Administration of an Extracellular Matrix Hydrogel, VentriGel, Following Myocardial Infarction
Ventrix, Inc.12 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 12
- 主要终点
- Incidence of serious adverse events that occur within 6 months of injection
研究概览
简要总结
This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the past 3 years and have evidence of left ventricular remodeling.
详细描述
Evaluate the safety and feasibility of VentriGel delivered trans-endocardially to subjects with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints will look at efficacy variables of ESV, EDV, EF, scar mass.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is 30-75 years of age
- •The subject must be able to provide informed consent
- •At least 60 days and no more than 3 years will have passed since the first ST elevation myocardial infarction (Index STEMI) at time of VentriGel administration
- •The Index STEMI must meet the following criteria:
- •First time diagnosis of STEMI AND;
- •Meet the STEMI criteria of the American College of Cardiology (ACC)/American Heart Association (AHA) (e.g. ST elevation in at least 2 contiguous leads >0.2 mV in V1, V2 or V3 and/or >0.1mV in at least two other leads), or new left bundle branch block (LBBB)
- •Evidence of left ventricular remodeling secondary to the myocardial infarction using 2-D echocardiography or cMR;
- •the LVEF must be ≥ 25% and ≤ 45% AND;
- •The left ventricular wall thickness is ≥ 8 mm in target area.
- •Successful percutaneous coronary intervention (PCI) restoring TIMI II of higher flow to infarcted area
- •Negative pregnancy test [serum human chorionic gonadotropin (βhCG)] in women of childbearing potential within 24 hours prior to dosing) or if less than 2 years postmenopausal agree to use of adequate contraception during the study.
- •Must be ambulatory, willing and able to comply with protocol, including follow-up visits
- •Subject must be receiving best medical treatment for their post-MI clinical presentation according to the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
- •For those subjects indicated for heart failure medical therapy, subjects must be on stable therapy including beta-blockers and angiotensin converting enzyme inhibitors, if tolerated, for at least 45 days prior to therapy delivery
排除标准
- •Contraindications to cardiac MR
- •NYHA Functional Classification 4 heart failure within the prior 6 months.
- •Significant coronary artery stenosis that may require percutaneous or surgical revascularization within six months of enrollment, as determined by the principal investigator
- •Left ventricular thrombus, left ventricular aneurysm, subjects with post-infarction pericarditis, or subjects with wall motion abnormalities outside the region of the infarct related artery
- •Frequent, recurrent, sustained (>30 seconds) ventricular tachycardia in 30 days prior to VentriGel administration
- •ECG or 24 hour Holter Monitor with any of the following findings:
- •Bifascicular block (left bundle branch block or right bundle branch block plus left hemi-block)
- •Higher grade AV block (i.e. 3rd degree)
- •Ventricular tachycardia (>= 5 seconds of VT OR any symptomatic VT)
- •Atrial fibrillation with heart rate greater than 110 bpm.
- •Severe valvular disease (e.g. aortic stenosis of moderate or worse severity, valvular insufficiency requiring surgical repair) or history of heart valve replacement.
- •Known allergy to porcine proteins or prior implantation of a porcine derived medical product including cardiac valves or other ECM products.
- •Etiology of heart failure due to any cause (e.g. hypertrophic cardiomyopathies, restrictive cardiomyopathies, constrictive pericardial disease, amyloidosis, active myocarditis) other than the index MI.
- •Severe peripheral vascular disease that impairs femoral arterial access.
- •Less than 3 years, cancer free, since end of treatment for cancer (with exception of basal cell carcinoma)
- •Alcohol or drug dependency within six months prior to enrollment
- •Cerebrovascular event within the 90 days prior or major surgical procedure or major trauma within the 14 days prior to enrollment
- •Participation, defined as receiving test article, in an experimental clinical study within 30 days prior to administration of VentriGel (i.e. screen failure from other study does not exclude subject)
- •Uncontrolled hypertension defined as systolic blood pressure (SBP) > 180 mmHg and/or or diastolic blood pressure (DBP) >110 mmHg
- •Abnormal laboratory values as defined below performed at screening:
- •Aspartate aminotransferase [AST]/ alanine aminotransferase [ALT] ≥ 3 times upper limit of normal (ULN)
- •Serum creatinine ≥ 2.0 mg/dL
- •Platelet count < 50,000/mm3
- •Hemoglobin < 9.0 g/dL
- •HbA1c > 9.0%
- •PT or aPTT with clinically significant elevations relative to local laboratory norms
- •Any other cardiac or non-cardiac conditions or illness which, in the opinion of the principal investigator, may place subjects at undue risk or compromise the objectives of the study.
- •Institutional interpretation of cMR EF data outside the ≥ 25% and ≤ 45% limits
研究组 & 干预措施
Post Myocardial Infarction
Experimental
VentriGel will be injected via a MyoStar catheter after NOGA mapping in the 60 day to 3 year window since the first STEMI myocardial infarction
干预措施: VentriGel (Biological)
结局指标
主要结局
Incidence of serious adverse events that occur within 6 months of injection
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (12)
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