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Syncardia 70cc Temporary Total Artificial Heart Destination Therapy Study

Condition: Heart failure

Eligibility

Key Inclusion Criteria (for primary group)

  • Life-threatening, irreversible biventricular heart failure
  • Ineligible for cardiac transplantation as determined by the implanting center at time of implant screening assessment
  • Ambulatory without assistance
  • 19-75 years old

Key Exclusion Criteria (for primary group)

  • Cardiac transplant-eligible patients
  • Patients who cannot be adequately anticoagulated on the TAH-t
  • Patients with insufficient space in the chest
  • Patients on extracorporeal membrane oxygenation support
Please See Detailed List of Inclusion and Exclusion Criteria

Full Study Name

Syncardia 70cc Temporary Total Artificial Heart (TAH-T) for Destination Therapy (DT) Study (IRB no. 39776)

Summary

The purpose of this study is to test the investigational use of the SynCardia 70cc Temporary Total Artificial Heart (TAH-T) as a permanent option for the treatment of biventricular heart failure in patients who are not currently eligible for heart transplantation. Researchers will evaluate whether the TAH-T can support patients with life-threatening, irreversible heart failure who are not candidates for a left ventricular assist device and have no other viable treatment options.

The SynCardia 70cc temporary Total Artificial Heart is currently approved by the U.S. Food and Drug Administration (FDA) for use as a bridge (temporary solution) to transplant (BTT) for patients at risk of imminent death due to irreversible, complete heart failure while waiting for a donor heart. However, the TAH-T is not approved by the FDA for use in patients who are not eligible for heart transplantation.

Principal Investigator

Alfred Trento, MD

Contact