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

Heart Failure Clinical Trial

Official title:

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583661
• Other study ID #: EXCOR® Pediatric
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: March 13, 2013
• Start date: May 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: Berlin Heart, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

Device:
• EXCOR Pediatric
Extracorporeal Ventricular Assist Device

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	The Children's Hospital Denver	Denver	Colorado
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota - Fairview	Minneapolis	Minnesota
United States	The Mt. Sinai Hospital	New York	New York
United States	Lucille Packard Children's Hospital / Stanford University	Palo Alto	California
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington
United States	St. Louis Children's Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Berlin Heart, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.	The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.	Participants were followed while on device support, an average of 58 days	Yes
Primary	Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.	Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.	Participants were followed while on device support, an average of 58 days	No

External Links

•   Berlin Heart Inc. Website