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SynCardia CardioWest TAH-t Postmarket Surveillance Study

NCT00614510 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2015-07-30

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.

Conditions

  • Biventricular Failure

Interventions

DEVICE

CardioWest temporary Total Artificial Heart (TAH-t)

The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines.

Sponsors & Collaborators

  • SynCardia Systems. LLC

    lead INDUSTRY

Principal Investigators

  • Jack G Copeland, MD · University Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2015-03-31
Completion
2015-03-31

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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 NCT00614510 on ClinicalTrials.gov