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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berlin Heart, Inc
ClinicalTrials.gov Identifier:
NCT00583661
First received: December 20, 2007
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: January 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Failure
Cardiomyopathies
Intervention: Device: EXCOR Pediatric

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject were recruited at pediatric transplant centers by the implanting physicians.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EXCOR Pediatric Implantation of the EXCOR Pediatric Ventricular Assist Device

Participant Flow:   Overall Study
    EXCOR Pediatric  
STARTED     48  
COMPLETED     48  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
EXCOR Pediatric Implantation of the EXCOR Pediatric Ventricular Assist Device

Baseline Measures
    EXCOR Pediatric  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     48  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: Months]
Median ( Full Range )
  64.3  
  ( 2.6 to 191.8 )  
Gender  
[units: participants]
 
Female     23  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     47  
Canada     1  



  Outcome Measures
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1.  Primary:   The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.   [ Time Frame: Participants were followed while on device support, an average of 58 days ]

2.  Primary:   Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.   [ Time Frame: Participants were followed while on device support, an average of 58 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert Kroslowitz, CEO
Organization: Berlin Heart Inc.
phone: 1-281-863-9700
e-mail: kroslowitz@berlinheart.com


No publications provided by Berlin Heart, Inc

Publications automatically indexed to this study:

Responsible Party: Berlin Heart, Inc
ClinicalTrials.gov Identifier: NCT00583661     History of Changes
Other Study ID Numbers: EXCOR® Pediatric
Study First Received: December 20, 2007
Results First Received: January 25, 2012
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration