SynCardia CardioWest TAH-t Postmarket Surveillance Study

Syncardia

Status: Completed

Conditions: Biventricular Failure

Treatments: Device: CardioWest temporary Total Artificial Heart (TAH-t)

Study type: Observational

Funder types: Industry

Identifiers

NCT00614510

P030011/S1

PR 05003

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Volunteers: No Healthy Volunteers

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.