SynCardia CardioWest TAH-t Postmarket Surveillance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Biventricular Failure

Study Design

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Observational Model Type

COHORT

Interventions

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CardioWest temporary Total Artificial Heart (TAH-t)

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No