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Trial record 1 of 1 for:    NCT00733447
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SynCardia Freedom Driver System Study

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. Inc.
ClinicalTrials.gov Identifier:
NCT00733447
First received: August 11, 2008
Last updated: July 1, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733447

Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
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: July 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by SynCardia Systems. Inc.:
Biventricular failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014