NCT00614510

Brief Summary

The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

August 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 30, 2015

Status Verified

March 1, 2015

Enrollment Period

8.6 years

First QC Date

January 30, 2008

Last Update Submit

July 28, 2015

Conditions

Biventricular Failure

Outcome Measures

Primary Outcomes (1)

  • Subject survival at 30-days and one-year post transplant

    30-days and one-year post transplant

Interventions

CardioWest temporary Total Artificial Heart (TAH-t)DEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been or will be implanted with the SynCardia Total Artificial Heart.

You may qualify if:

  • The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

You may not qualify if:

  • Patients who are not cardiac transplant eligible.
  • Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas \<1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) \< 10 cm.
  • Patients who cannot be adequately anticoagulated on the TAH-t.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jack G Copeland, MD

    University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 13, 2008

Study Start

August 1, 2006

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-03