Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device

NCT ID: NCT00583661

Last Updated: 2013-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).

Detailed Description

Berlin Heart Inc. is sponsoring a prospective, multi-center, single arm study to access the safety and probable benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR® Pediatric]. The study will compare the EXCOR® Pediatric with a historical control population supported with extra-corporeal membrane oxygenation (ECMO) as a bridge to cardiac transplantation in children.

Conditions

Heart Failure; Cardiomyopathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXCOR Pediatric

Implantation of the EXCOR Pediatric Ventricular Assist Device

Group Type: EXPERIMENTAL

EXCOR Pediatric

Intervention Type: DEVICE

Extracorporeal Ventricular Assist Device

Interventions

EXCOR Pediatric

Extracorporeal Ventricular Assist Device

Intervention Type: DEVICE

Other Intervention Names

Berlin Heart; EXCOR®; EXCOR® Pediatric Ventricular Assist Device; EXCOR® Pediatric VAD

Eligibility Criteria

Inclusion Criteria

• Severe New York Heart Association (NYHA) Functional Class IV (or Ross Functional Class IV for patients <= 6 years) heart failure refractory to optimal medical therapy, and has met at least one of the following criteria:

• Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile status 1 or 1a, i.e. critical cardiogenic shock (low BP unresponsive to support), compromised end organ perfusion, < 24 hour survival without mechanical support; may be due to Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) (1A) OR
• INTERMACS profile status 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: Decline in renal functions, Decline in nutritional status, Decline in mobility/ambulation

OR

• Support with extra-corporeal membrane oxygenation (ECMO) or other mechanical circulatory support device OR
• Unable to separate from cardiopulmonary bypass

• Listed (UNOS status 1A or equivalent) for cardiac transplantation
• Two-ventricle circulation, including cardiomypathy, repaired structural heart disease or acquired heart disease
• Age 0 to 16 years
• Weight >= 3 kg and <= 60 kg
• Legal guardian (and patient if age-appropriate) understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent and assent prior to the procedure

Exclusion Criteria

• Support on ECMO for >= 10 days
• Cardiopulmonary resuscitation (CPR) duration >= 30 minutes within 48 hours of implantation
• Body weight < 3.0 kg or Body Surface Area > 1.5 m2
• Presence of mechanical aortic valve
• Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy
• Evidence of intrinsic hepatic disease
• Evidence of intrinsic renal disease
• Evidence of intrinsic pulmonary disease
• Hemodialysis or peritoneal dialysis (not including dialysis or continuous veno-venous hemofiltration (CVVH) for fluid removal)
• Moderate or severe aortic and/or pulmonic valve insufficiency
• Apical Ventricular Septal Defects (VSD) or other compromise that is technically challenging to repair at implant
• Documented heparin induced thrombocytopenia (HIT)
• Documented coagulopathy
• Hematologic disorder
• Active Infection within 48 hours of implant (positive blood culture or White Blood Cell Count >15,000 and fever > 38 degrees C)
• Documented Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• Evidence of recent life-limiting malignant disease
• Stroke within 30 days prior to enrollment
• Psychiatric or behavioral disease
• Currently participating in another Investigational Device Exemption (IDE) or Investigational New Drug Application (IND) trial
• Patient is pregnant or nursing

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berlin Heart, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles D Fraser, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Texas Children's Hospital / Baylor College of Medicine

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Lucille Packard Children's Hospital / Stanford University

Palo Alto, California, United States

The Children's Hospital Denver

Denver, Colorado, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Children's Hospital of Boston

Boston, Massachusetts, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Minnesota - Fairview

Minneapolis, Minnesota, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

The Mt. Sinai Hospital

New York, New York, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Stollery Children's Hospital

Edmonton, Alberta, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

References

Jordan LC, Ichord RN, Reinhartz O, Humpl T, Pruthi S, Tjossem C, Rosenthal DN. Neurological complications and outcomes in the Berlin Heart EXCOR(R) pediatric investigational device exemption trial. J Am Heart Assoc. 2015 Jan 22;4(1):e001429. doi: 10.1161/JAHA.114.001429.

Reference Type: DERIVED

PMID: 25613996 (View on PubMed)

Fraser CD Jr, Jaquiss RD, Rosenthal DN, Humpl T, Canter CE, Blackstone EH, Naftel DC, Ichord RN, Bomgaars L, Tweddell JS, Massicotte MP, Turrentine MW, Cohen GA, Devaney EJ, Pearce FB, Carberry KE, Kroslowitz R, Almond CS; Berlin Heart Study Investigators. Prospective trial of a pediatric ventricular assist device. N Engl J Med. 2012 Aug 9;367(6):532-41. doi: 10.1056/NEJMoa1014164.

Reference Type: DERIVED

PMID: 22873533 (View on PubMed)

Almond CS, Buchholz H, Massicotte P, Ichord R, Rosenthal DN, Uzark K, Jaquiss RD, Kroslowitz R, Kepler MB, Lobbestael A, Bellinger D, Blume ED, Fraser CD Jr, Bartlett RH, Thiagarajan R, Jenkins K. Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: study design and rationale. Am Heart J. 2011 Sep;162(3):425-35.e6. doi: 10.1016/j.ahj.2011.05.026. Epub 2011 Jul 30.

Reference Type: DERIVED

PMID: 21884857 (View on PubMed)

Related Links

http://www.berlinheart.com

Berlin Heart Inc. Website

Other Identifiers

EXCOR® Pediatric

Identifier Type: -

Identifier Source: org_study_id