Multi-center study for EXP-01 Pediatric Ventricular Assist Device in pediatric severe heart failure patients
- Conditions
- Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant
- Registration Number
- JPRN-jRCT1092220087
- Lead Sponsor
- Ono, Minoru, MD, PhD, Cardiac Surgery, The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
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
criteria:
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
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
OR
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (efficacy) Subjects status will be evaluated during 3months after the initiation of mechanical support.<br>(safety) adverse event, device malfunction
- Secondary Outcome Measures
Name Time Method (efficacy)<br>1.The interval of time from initiation of mechanical support to the following event<br>2. Ability to de-intensify concomitant hemodynamic support by analyzing the subjects status