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Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

NCT03701997 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2018-10-10

No results posted yet for this study

Summary

The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (\<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.

Conditions

  • Ventricular Dysfunction
  • Ventricular Dysfunction, Left
  • Ventricular Dysfunction, Right

Interventions

DEVICE

EXCOR Pediatric

Mechanical circulatory support using 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
2018-10-15
Primary Completion
2021-12-31
Completion
2022-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03701997 on ClinicalTrials.gov