SynCardia Freedom Driver System Study

Biventricular Failure Clinical Trial

Official title:

SynCardia Freedom Driver System Study

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00733447
• Other study ID #: RA-142
• Secondary ID: P030011
• Status: Approved for marketing
• Phase: N/A
• First received: August 11, 2008
• Last updated: July 28, 2015
• Start date: March 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: SynCardia Systems. Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Biventricular Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
SynCardia Systems. Inc.

Country where clinical trial is conducted

United States,