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.
Brief Title
SynCardia CardioWest TAH-t Postmarket Surveillance Study
Categories
Completion Date
Completion Date Type
Actual
Conditions
Biventricular Failure
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
NCT Id
NCT00614510
Org Class
Industry
Org Full Name
SynCardia Systems. LLC
Org Study Id
PR 05003
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study
Primary Outcomes
Outcome Measure
Subject survival at 30-days and one-year post transplant
Outcome Time Frame
30-days and one-year post transplant
Secondary Ids
Secondary Id
P030011/S1
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients who have been or will be implanted with the SynCardia Total Artificial Heart.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Goldstein
Investigator Email
dgoldste@montefiore.org
Investigator Phone