SynCardia CardioWest TAH-t Postmarket Surveillance Study

SynCardia Systems. LLC196 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

196

Conditions

Biventricular Failure

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

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 30-days and one-year post transplant

Data from ClinicalTrials.gov

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