JPRN-jRCT1092220087已完成Unknown
Multi-center study for EXP-01 Pediatric Ventricular Assist Device in pediatric severe heart failure patients
Ono, Minoru, MD, PhD, Cardiac Surgery, The University of Tokyo Hospital0 个研究点目标入组 3 人开始时间: 2012年4月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 至 <= 14age old（—）
- 性别
- All
入选标准
- •1. Listed for cardiac transplantation(Japan organ transplant network)
- •2 Age 0 to 14 years; corrected gestational (CGA) at least 37 weeks
- •3 Weight ? 3 kg or < 50 kg and Body surface area <1.5 m2
- •4. Severe NYHA Functional Class IV (or Ross Functional Class IV for subjects ?6 years) heart
- •failure refractory to optimal medical therapy, and has met at least one of the following
- •a. J-MACS profile status 1 or 1A, i.e. critical cardiogenic shock (low BP
- •unresponsive to support), compromised end organ perfusion, < 24 hour survival
- •expected without mechanical support; may be due to VT/VF (1A)
- •b.J-MACS profile status 2 or 2A (i.e. progressive decline): not in imminent
- •danger, but worsening despite optimal inotropic therapy; may be due to VT/VF
- •(2A) AND at least one of the following criteria
- •i. Decline in renal function as defined by a 50% reduction in estimated GFR
- •despite optimization of subject volume status
- •ii. Decline in nutritional status as defined by a sustained (?7 days) inability
- •to tolerate an enteral nutritional intake sufficient to provide at least 75%
- •of the prescribed caloric needs for the subject, or signs of nutritional
- •compromise (cachexia, nutritional weight loss) despite appropriate
- •intervention
- •iii. Decline in mobility/ambulation as defined by sustained bed confinement
- •(?7 days without prospect for improvement) attributable to heart failure
- •symptoms or its treatment (e.g. intubation for pulmonary edema)
- •c. Support with extra-corporeal membrane oxygenation (ECMO) or other
- •mechanical circulatory support device
- •5. Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g.
- •ALCAPA, aortic stenosis) or acquired heart disease (e.g. myocarditis, Kawasaki disease)
- •6. Legal guardian (and subject if age-appropriate) understands the nature of the procedure, are
- •willing to comply with associated follow-up evaluations, and provide written informed
- •consent and assent prior to the procedure
排除标准
- •1. Support on ECMO for ?10 days
- •2. Cardiopulmonary resuscitation (CPR) duration ?30 minutes within 48 hours prior to device
- •implantation
- •3. Presence of mechanical aortic valve
- •4. Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions,
- •complex heterotaxy, and restrictive cardiomyopathy
- •5. Evidence of intrinsic hepatic disease, except in association with acute heart failure
- •as determined by the principal investigator
- •6. Evidence of intrinsic renal disease, except in association with acute heart failure as determined by the principal investigator
- •7. Hemodialysis or peritoneal dialysis (not including dialysis or Continuous Veno-Venous
- •Hemofiltration (CVVH) for volume removal)
- •8. Evidence of intrinsic pulmonary disease (e.g. chronic lung disease, RDS) as defined by need
- •for chronic mechanical ventilation, except in association with acute heart failure as
- •determined by the principal investigator
- •9. Moderate or severe aortic and/or pulmonic valve insufficiency considered technically
- •challenging to repair at the time of the device implantation as determined by the principal
- •investigator
- •10. Apical VSD or other hemodynamically-significant lesion considered technically challenging
- •to repair at the time of device implantation as determined by the principal investigator
- •11. Documented heparin induced thrombocytopenia (HIT) or idiopathic thrombocytopenia
- •purpura (ITP) or other contraindication to anticoagulant/antiplatelet therapy
- •12. Documented coagulopathy (e.g. Factor VIII deficiency, disseminated intravascular
- •coagulation) or thrombophilic disorder (e.g. Factor V Leiden mutation)
- •13. Hematologic disorder causing fragility of blood cells or hemolysis (e.g. sickle cell disease)
- •14. Active infection within 48 hours of implant demonstrated by:
- •a. Positive blood culture
- •b. Temperature >38 degrees C and WBC >15, 000/ ml
- •15. Documented human immunodeficiency virus (HIV) infection or acquired immunodeficiency
- •syndrome (AIDS)
- •16. Evidence of recent or life-limiting malignant disease
- •17. Stroke within past 30 days prior to enrollment, or congenital CNS malformation syndrome
- •associated with increased risk of bleeding (e.g. arteriovenous malformation, moya moya)
- •18. Psychiatric or behavioral disease (e.g. antisocial disorder) with a high likelihood for noncompliance
- •19. Currently participating in another investigational device or drug trial and has not completed
- •the required follow-up period for that study
- •20. Subjects who are not appropriate to participate to the trial
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