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Investigational Use Studies

SynCardia is Conducting Two FDA-Approved Clinical Studies in the U.S.

50cc and 70cc SynCardia Total Artificial Heart


50cc SynCardia temporary Total Artificial Heart for Bridge to Transplant

In Europe, the 50cc Total Artificial Heart has the CE Mark for use as a bridge to donor heart transplant.

In the U.S., SynCardia is conducting an FDA-approved Investigational Device Exemption (IDE) clinical study of the 50cc Total Artificial Heart as a bridge to donor heart transplant (ClinicalTrials.gov Identifier: NCT02459054).

Study Arms:

  1. Primary Arm: Implant as a bridge to donor heart transplant in 24 adult patients.
  2. Primary Arm: Implant as a bridge to donor heart transplant in 24 pediatric patients.
  3. Secondary Arm: Implant as a bridge to donor heart transplant in 24 adult and pediatric patients who do not meet all of the Primary Arm patient enrollment criteria.

Primary Arm Patient Enrollment Criteria

  • At risk of imminent death from biventricular heart failure
  • Eligible for donor heart transplant
  • Has two functional atrioventricular (A-V) valves
  • BSA of 1.2m² through 1.85m² with adequate T10 measurement or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments
  • For adults, ages 19-75 years at time of implant
  • For pediatric patients, ages 10-18 years at time of implant

SynCardia may pursue a destination therapy study of the 50cc heart with adult patients.


70cc SynCardia Total Artificial Heart for Destination Therapy

The FDA has approved a Humanitarian Use Device (HUD) designation for the 70cc Total Artificial Heart to be used for destination therapy (DT) for adults.

The FDA has also approved an Investigational Device Exemption (IDE) clinical study to support FDA approval of a Humanitarian Device Exemption (HDE) application (ClinicalTrials.gov Identifier: NCT02232659).

Study Arms:

  1. Primary Arm: Implant as destination therapy in 19 patients to demonstrate the safety and probable benefit for Humanitarian Device Exemption (HDE).
  2. Secondary Arm: Implant as destination therapy in up to 19 patients who do not meet all of the Primary Arm patient enrollment criteria.

Primary Arm Patient Enrollment Criteria

  • 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
  • Between 19 and 75 years old
  • Body surface area (BSA) ≥ 1.7m²
  • Adequate T10 measurement or adequate room in the chest as determined by 3D imaging assessment or other standard clinical assessments.

The Centers for Medicare & Medicaid Services (CMS) has determined that the SynCardia 70cc Total Artificial Heart for destination therapy 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.

CAUTION – In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by federal law to investigational use.

CAUTION – The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.

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