Sunshine Heart Halts Trial Enrollment After Patient Deaths

Sunshine Heart has halted enrollment in a pivotal clinical trial of its C-Pulse heart failure system following the deaths of four patients, the company said Friday, adding it will file an IDE supplement with the FDA explaining the move and its plans for resuming the study by March 16.

The action is dictated by the COUNTER HF trial’s protocol, which says that if more than three of the first 20 subjects die for any reason, the devicemaker will suspend enrollment and work with the FDA to devise a plan to resume it.

Of the four reported deaths, two were found by an independent panel to be nondevice-related, Sunshine said. The two other deaths were also nondevice-related, according to documentation from the trial sites, the company said.

“While the current data suggest these incidents are nondevice-related, we have decided that in the absolute interest of patient safety, having a temporary pause in enrollment is the right course of action while we work with the FDA to discuss the findings,” said Sunshine Heart President and CEO Dave Rosa. He added that the company is confident the matter will be resolved in a short amount of time.

According to the company, the C-Pulse system utilizes intra-aortic balloon counter-pulsation technology applied in an extra-aortic approach to reduce the effort required by the left ventricle to pump blood throughout the body, while increasing blood flow to the coronary arteries.

The company will continue to screen potential enrollees during the FDA review, Rosa said. — Kellen Owings