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Berlin Heart EXCOR Pediatric Post Approval Study

NCT01674699 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2012-08-29

No results posted yet for this study

Summary

The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE study.

Conditions

  • Severe Isolated Left Ventricular Dysfunction
  • Severe Biventricular Dysfunction

Interventions

DEVICE

EXCOR Pediatric

Ventricular Assist Device

Sponsors & Collaborators

  • Berlin Heart, Inc

    lead INDUSTRY

Principal Investigators

  • Robert M Kroslowitz, BS · Berlin Heart, Inc

Eligibility

Min Age
1 Day
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-06-30
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674699 on ClinicalTrials.gov