MedTrace Logo

SynCardia Freedom Driver System Study

NCT00733447 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2015-07-30

No results posted yet for this study

Summary

The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.

Conditions

  • Biventricular Failure

Interventions

DEVICE

CardioWest temporary Total Artificial Heart (TAH-t) System

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 pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines.

Sponsors & Collaborators

  • SynCardia Systems. LLC

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-08-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00733447 on ClinicalTrials.gov