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New clinical trial will study smaller version of temporary total artificial heart
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SynCardia Systems, Inc. announced FDA approval of a clinical trial to investigate a smaller version of its temporary artificial heart as a bridge to donor heart transplant in patients with HF, according to a press release.
The 50cc SynCardia Total Artificial Heart is intended for smaller patients who are unable to use the larger 70cc SynCardia Total Artificial Heart.
The trial is approved for up to 30 patients with HF who are eligible for transplantation, including 10 pediatric patients aged 10 to 18 years, 10 adult patients aged 19 to 75 years and a secondary, 10-patient group consisting of patients who would not otherwise qualify according to the study criteria. Researchers will perform 3D modeling of the chests of all participants.
Each patient will be followed for up to 2 years. Data at 6 months will be submitted to the FDA in pursuit of approval for the 50cc device, according to the release.
The 50cc version is an investigational device in the U.S. and the 70cc version is approved for temporary treatment of end-stage biventricular HF.