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

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

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