Thoratec Begins Shield II United States Clinical Trial

September 8, 2015—Thoratec Corporation announced that it has begun enrollment in the SHIELD II United States clinical trial examining the HeartMate PHP (percutaneous heart pump) in patients undergoing high-risk percutaneous coronary intervention (PCI). The first case in the trial was performed by Robert Pyo, MD, at Montefiore Medical Center in New York, New York. 

SHIELD II is an investigation of supporting patients undergoing high-risk PCI using a high-flow percutaneous left ventricular support device. In July, Thoratec announced European CE Mark approval for the HeartMate PHP. 

According to Thoratec, the trial will be composed of up to 425 patients enrolled at up to 60 sites in the United States. Patients will be randomized to the HeartMate PHP or the Impella 2.5 (Abiomed, Inc.) at a 2:1 ratio. Individual sites may immediately begin randomization after performing a series of one to three HeartMate PHP procedures for purposes of training and familiarity. The primary endpoint will measure noninferiority based on a composite of adverse events at 90 days of follow-up. 

The study will be led by three National Principal Investigators: Ulrich Jorde, MD, of Montefiore Medical Center; David Kandzari, MD, of Piedmont Heart Institute in Atlanta, Georgia; and Navin Kapur, MD, of Tufts University Medical Center in Boston, Massachusetts. 

In Thoratec’s press release, Dr. Kandzari commented, “We expect that data from SHIELD II will further demonstrate the clinical value of PHP, and could not only advance the rapidly emerging market for percutaneous hemodynamic support in complex coronary revascularization but also support further study in expanded indications.”

Dr. Jorde added, “SHIELD II is off to an encouraging start as the HeartMate PHP was easily deployed and provided consistent hemodynamic stability during the first case.”

Thoratac stated that the HeartMate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. The expandable catheter technology of HeartMate PHP is capable of generating average blood flow of four to five liters per minute following delivery through a true percutaneous insertion. The device has been designed for hemocompatibility, with typical operating speeds between 17,000–20,000 rpm.