Thoratec Begins Enrollment in Shield II Trial

Pleasanton, Calif.-based Thoratec Corporation, which makes mechanical circulatory support therapies for failing hearts, has begun enrollment in its Shield II U.S. clinical trial examining the Heartmate PHP in patients undergoing a high-risk PCI (percutaneous coronary intervention) procedure.

The first case was performed by interventional cardiologist Robert Pyo, M.D., at Montefiore Medical Center.

“Shield II is off to an encouraging start as the Heartmate PHP was easily deployed and provided consistent hemodynamic stability during the first case,” said Ulrich Jorde, M.D., vice chief of cardiology and section head of heart failure, cardiac transplantation, and mechanical circulatory support at Montefiore Medical Center, Albert Einstein College of Medicine, New York.

“Shield II marks the beginning of our clinical experience with PHP in the large and important U.S. market,” said D. Keith Grossman, president and CEO of Thoratec. “We look forward to the significant clinical data expected from Shield II and the ultimate commercialization of PHP in the United States.”

Heartmate PHP is an acute cardiac assist device designed to uncouple the traditional relationship between size and flow in catheter-based support devices. The proprietary expandable catheter technology of Heartmate PHP is reportedly 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 RPMs (revolutions per minute).

The Shield II (Supporting patients undergoing high-risk PCI using a high-flow percutaneous left ventricular support device) U.S. clinical trial will randomize up to 425 patients at up to 60 sites against Abiomed’s Impella 2.5 device 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 non-inferiority 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, M.D., of Montefiore Medical Center, David Kandzari, M.D., of Piedmont Heart Institute, and Navin Kapur, M.D., of Tufts University Medical Center.

“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,” said Kandzari, director of interventional cardiology and chief scientific officer at Piedmont.