Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol

Heart Failure Clinical Trial

— CAP  

Official title:

A Prospective, Multi-center, Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (EXCOR® Pediatric)Under a Continued Access Protocol.

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01242891
• Other study ID #: EXCOR® Continued Access
• Status: Approved for marketing
• Phase: N/A
• First received: November 16, 2010
• Last updated: March 2, 2012

Study information

• Verified date: March 2012
• Source: Berlin Heart, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.

Description:

The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR® Pediatric Ventricular Assist Device. This protocol was closed at the same time as the main IDE study due to FDA approval (December 16, 2011).

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• 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:

• 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 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 IDE or IND trial

• Patient is pregnant or nursing

Study Design

N/A

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

Device:
• EXCOR® Pediatric Ventricular Assist Device
Extracorporeal Ventricular Assist Device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Berlin Heart, Inc

External Links

•   Berlin Heart Inc