SynCardia CardioWest TAH-t Postmarket Surveillance Study
Completed
- Conditions
- Biventricular Failure
- Registration Number
- NCT00614510
- Lead Sponsor
- SynCardia Systems. LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject survival at 30-days and one-year post transplant 30-days and one-year post transplant
- Secondary Outcome Measures
Name Time Method