NCT00733447

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

3.4 years

First QC Date

August 11, 2008

Last Update Submit

July 28, 2015

Conditions

Biventricular Failure

Keywords

Biventricular failure

Interventions

CardioWest temporary Total Artificial Heart (TAH-t) SystemDEVICE

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 Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are implanted with the TAH-t and are not clinically stable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

March 1, 2010

Primary Completion

August 1, 2013

Study Completion

May 1, 2014

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

US(3)