SynCardia CardioWest TAH-t Postmarket Surveillance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. Inc.
ClinicalTrials.gov Identifier:
NCT00614510
First received: January 30, 2008
Last updated: July 1, 2014
Last verified: July 2014
  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. Inc.:

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

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614510

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

No publications provided

Responsible Party: SynCardia Systems. Inc.
ClinicalTrials.gov Identifier: NCT00614510     History of Changes
Other Study ID Numbers: PR 05003, P030011/S1
Study First Received: January 30, 2008
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014