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Trial record 1 of 1 for:    NCT00614510
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SynCardia CardioWest TAH-t Postmarket Surveillance Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614510
First Posted: February 13, 2008
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SynCardia Systems. LLC
  Purpose
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.

Condition Intervention
Biventricular Failure Device: CardioWest temporary Total Artificial Heart (TAH-t)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study

Further study details as provided by SynCardia Systems. LLC:

Primary Outcome Measures:
  • Subject survival at 30-days and one-year post transplant [ Time Frame: 30-days and one-year post transplant ]

Enrollment: 196
Study Start Date: August 2006
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been or will be implanted with the SynCardia Total Artificial Heart.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614510


Sponsors and Collaborators
SynCardia Systems. LLC
Investigators
Principal Investigator: Jack G Copeland, MD University Medical Center
  More Information

Responsible Party: SynCardia Systems. LLC
ClinicalTrials.gov Identifier: NCT00614510     History of Changes
Other Study ID Numbers: PR 05003
P030011/S1
First Submitted: January 30, 2008
First Posted: February 13, 2008
Last Update Posted: July 30, 2015
Last Verified: March 2015