COUNTER HF™ Heart Failure Clinical Study
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse Heart Assist System.
Sunshine Heart received approval from the FDA in November 2012 to initiate its pivotal study. The purpose of the study is to determine whether the use of the C-Pulse System, as a treatment for patients in moderate to severe heart failure (HF), has demonstrated safety and efficacy such that the C-Pulse merits Food and Drug Administration (FDA) approval to market the device in the United States.
The primary study population will include 388 subjects enrolled and randomized in up to 40 centers in the United States (US). The treatment group will include 194 subjects randomized to and implanted with C-Pulse System and the control group will include 194 subjects randomized to Optimal Medical Therapy (OMT) and follow the same schedule as the treated subjects.
OPTIONS HF Post Market Clinical Study
In July 2012, Sunshine Heart received CE Mark to distribute the C-Pulse System in Europe. Sunshine Heart is sponsoring a prospective, multi-center, open label post market study to collect additional clinical outcomes data. The primary study population will include up to 50 patients with moderate to severe heart failure who receive the C-Pulse System. Subjects will be followed up for 5 years to collect additional data for reimbursement and publications. A maximum of 15 European sites will participate.