SynCardia CardioWest TAH-t Postmarket Surveillance Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. Inc.
ClinicalTrials.gov Identifier:
NCT00614510
First received: January 30, 2008
Last updated: February 24, 2014
Last verified: February 2014

January 30, 2008
February 24, 2014
August 2006
June 2014   (final data collection date for primary outcome measure)
Subject survival at 30-days and one-year post transplant [ Time Frame: 30-days and one-year post transplant ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00614510 on ClinicalTrials.gov Archive Site
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SynCardia CardioWest TAH-t Postmarket Surveillance Study
The SynCardia CardioWest Temporary Total Artificial Heart (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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Observational
Observational Model: Cohort
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Non-Probability Sample

Patients who have been or will be implanted with the SynCardia Total Artificial Heart.

Biventricular Failure
Device: 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
September 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00614510
PR 05003, P030011/S1
Yes
SynCardia Systems. Inc.
SynCardia Systems. Inc.
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Principal Investigator: Jack G Copeland, MD University Medical Center
SynCardia Systems. Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP