U.S. Clinical Trials

As the world leader in heart replacement technology, we are committed to advancing the treatment of end-stage biventricular failure to help improve patient care, quality of life and long-term outcomes. Clinical trials of new products and indications allow patients who might otherwise be out of options to access novel and potentially lifesaving treatments and technologies. Whether you are a study subject or a study site, your participation in SynCardia clinical trials is critical to helping more end-stage heart failure patients live longer, better lives.

Interested in becoming a study site for one of our clinical trials? Contact us here.

70cc Total Artificial Heart for Destination Therapy

ClinicalTrials.gov Identifier: NCT02232659

Approved as a bridge to transplant by the FDA in 2004, the 70cc Total Artificial Heart is currently undergoing an IDE clinical trial for use as destination therapy in adult patients who are not eligible for heart transplantation.

Through this clinical trial, patients who normally would not meet eligibility criteria to receive the 70cc TAH can now access this life-saving treatment option.

As a bridge to transplant, the 70cc TAH has supported more than 1,700 patients worldwide, accounting for more than 600 patient-years of support. Several patients have been supported by the 70cc TAH for more than 4.5 years.

Study Arms:

  • Primary Arm: 19 adult patients

    Will evaluate the safety and probable benefit of the 70cc TAH for patients not eligible for transplant to support a HDE application

  • Secondary Arm: Up to 19 patients who do not meet all of the Primary Arm patient enrollment criteria

Reimbursement:

CMS has determined that the SynCardia 70cc Total Artificial Heart for Destination Therapy Study fulfills the requirement of the NCD for artificial hearts and related devices. This provides coverage with evidence development approved by CMS for reimbursement.

Primary Arm Patient Enrollment Criteria include:

  • Life-threatening, irreversible biventricular heart failure

  • Not eligible for donor heart transplant

  • On optimal medical management and failing to respond or failing DT ventricular assist device (VAD) therapy

  • Ambulatory without assistance

  • Not on ECMO support or diagnosed with renal dysfunction, cardiac cachexia or cirrhosis

  • Between 19 and 75 years old

  • BSA ≥ 1.7m2 or with T10 measurement* ≥ 10 cm

Patients who do not meet all the above criteria may still be able to participate in the clinical trial via enrollment in the Secondary Arm.

*posterior sternum to anterior spine measurement at T10

Study Principal Investigator:

  • Jack Copeland, MD