SynCardia Freedom Driver System Study

Expanded access is currently available for this treatment.
Verified February 2014 by SynCardia Systems. Inc.
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. Inc.
ClinicalTrials.gov Identifier:
NCT00733447
First received: August 11, 2008
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Biventricular Failure
Device: CardioWest temporary Total Artificial Heart (TAH-t) System

Study Type: Expanded Access     What is Expanded Access?
Official Title: SynCardia Freedom Driver System Study

Further study details as provided by SynCardia Systems. Inc.:

Study Start Date: March 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are implanted with the TAH-t and are clinically stable.

Exclusion Criteria:

  • Patients who are implanted with the TAH-t and are not clinically stable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733447

Contacts
Contact: Michael Garippa 520 618-1853 mgarippa@syncardia.com
Contact: Judith Skroback 520 547-7466 jskroback@syncardia.com

Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Principal Investigator: Dawn Jaroszewski, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Michael Acker, MD         
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Principal Investigator: Vigneshwar Kasirajan, MD         
Sponsors and Collaborators
SynCardia Systems. Inc.
  More Information

No publications provided

Responsible Party: SynCardia Systems. Inc.
ClinicalTrials.gov Identifier: NCT00733447     History of Changes
Other Study ID Numbers: RA-142, P030011
Study First Received: August 11, 2008
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by SynCardia Systems. Inc.:
Biventricular failure

ClinicalTrials.gov processed this record on April 14, 2014