SynCardia CardioWest TAH-t Postmarket Surveillance Study

Biventricular Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614510
• Other study ID #: PR 05003
• Secondary ID: P030011/S1
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: July 28, 2015
• Start date: August 2006
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: SynCardia Systems. Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Biventricular Failure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SynCardia Systems. Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject survival at 30-days and one-year post transplant		30-days and one-year post transplant	Yes