Thoratec announces start of SHIELD II US clinical trial


Thoratec has begun enrolment in the SHIELD II US clinical trial examining the HeartMate PHP in patients undergoing a high-risk percutaneous coronary intervention (PCI) procedure. The first case was performed by interventional cardiologist Robert Pyo at Montefiore Medical Center, Albert Einstein College of Medicine, New York, USA.

“SHIELD II is off to an encouraging start as the HeartMate PHP was easily deployed and provided consistent haemodynamic stability during the first case,” said Ulrich Jorde, vice chief of cardiology and section head of heart failure, cardiac transplantation, and mechanical circulatory support at Montefiore Medical Center.

“SHIELD II marks the beginning of our clinical experience with PHP in the large and important US market,” said D Keith Grossman, president and chief executive officer. “We look forward to the significant clinical data expected from SHIELD II and the ultimate commercialisation of PHP in the USA,” he added. 

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 capable of generating average blood flow of four to five litres per minute following delivery through a true percutaneous insertion. The device has been designed for haemocompatibility, with typical operating speeds between 17,000–20,000 RPMs. 

The SHIELD II (Supporting patients undergoing high-risk PCI using a high-flow percutaneous left ventricular support device) US clinical trial will randomise up to 425 patients at up to 60 sites against the Impella 2.5 at a 2:1 ratio. Individual sites may immediately begin randomisation 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 of Montefiore Medical Center, David Kandzari of Piedmont Heart Institute, and Navin Kapur 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 haemodynamic support in complex coronary revascularisation but also support further study in expanded indications,” said Kandzari, director of interventional cardiology and chief scientific officer at Piedmont.