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.

50cc Total Artificial Heart for Bridge to Transplant

ClinicalTrials.gov Identifier: NCT02459054

The 50cc Total Artificial Heart (TAH) is undergoing the first-ever FDA clinical trial of a biventricular replacement device intended for use in pediatric patients and adults of smaller stature as a bridge to transplant.

Through this Investigational Device Exemption (IDE) clinical trial, patients too small to receive the PMA-approved 70cc Total Artificial Heart now have access to the smaller 50cc TAH. Worldwide, 61% of 50cc TAH implants have been in women, compared to only 11% of 70cc TAH implants. In addition, 18% of 50cc TAH implants have been in pediatric patients (< 18 years old), compared to only 2% of 70cc TAH implants.

Study Arms:

  • Pediatric Primary Arm: 24 pediatric patients (10-18 years old)

    Will evaluate the safety and probable benefit of the 50cc TAH for transplant-eligible pediatric patients to support a Humanitarian Device Exemption (HDE) application

  • Adult Primary Arm: 24 adult patients (19-75 years old)

    Will evaluate the safety and efficacy of the 50cc TAH for transplant-eligible adult patients to support a Premarket Approval (PMA) application

  • Secondary Arm:

    Up to 24 adult and pediatric patients who do not meet all of the Primary Arm patient enrollment criteria

Primary Arm Patient Enrollment Criteria include:

  • At risk of imminent death from biventricular heart failure

  • At time of implant, age 10-18 years (pediatric) or 19-75 years (adults)

  • Eligible for donor heart transplant

  • Have two functional atrioventricular (A-V) valves

  • On ECMO support ≤ 3 days and not dialysis-dependent

  • Have a BSA ≤ 1.85m2 with adequate T10 measurement* or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments

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

Reimbursement:

The Centers for Medicare & Medicaid Services (CMS) has determined that the SynCardia 50cc Total Artificial Heart for Bridge to Transplant Study fulfills the requirement of the National Coverage Decision (NCD) for artificial hearts and related devices. This provides coverage with evidence development approved by CMS for reimbursement.

Study Principal Investigators:

  • David L. S. Morales, MD, Cincinnati Children’s Hospital Medical Center (Pediatric Arm)

  • Francisco Arabia, MD, Cardiac-Dynamics (Adult Arm)

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