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OpenTrials
Completed

NCT Number: NCT00614510

SynCardia CardioWest TAH-t Postmarket Surveillance Study

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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Key information

Conditions

Biventricular Failure

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

SynCardia Systems. LLC

Industry

Registry information

Official study title

The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2008
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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