- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242891
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol (CAP)
March 2, 2012 updated by: Berlin Heart, Inc
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.
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.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 16 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: All Previous IDE Sites, See IDE Clinical Trials Listing for IDE Study
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 16, 2010
First Submitted That Met QC Criteria
November 16, 2010
First Posted (Estimate)
November 17, 2010
Study Record Updates
Last Update Posted (Estimate)
March 6, 2012
Last Update Submitted That Met QC Criteria
March 2, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXCOR® Continued Access
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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