Trials & Outcomes
HeartMate 3™ Clinical Trial
The MOMENTUM 3 trial is a prospective, multi-center, unblinded randomized study comparing the HeartMate 3 Left Ventricular Assist System (LVAS) to the HeartMate II LVAS in advanced stage heart failure patients.
The ROADMAP Study Results
The ROADMAP study is the first trial to explore the use of LVAD support in patients who are not yet treated with inotropic support and meet the FDA approved indications for HeartMate II destination therapy. This prospective clinical evaluation compared outcomes of patients with advanced ambulatory heart failure treated with either a HeartMate II LVAD or optimal medical management. ROADMAP results support the use of HeartMate II LVAD in this patient population.
HeartMate II Clinical Trial Results
As Thoratec's first-line intermediate-to-chronic left ventricular assist device, the HeartMate II is the most widely used, extensively studied LVAD in the world as Bridge-to-Transplantation and Destination Therapy (i.e. for patient ineligible for cardiac transplant) for advanced heart failure.
The SHIELD II Trial is a prospective, randomized, multi-center, open-label study evaluating the safety and effectiveness of HeartMate PHP™ (Percutaneous Heart Pump) in patients undergoing high-risk percutaneous coronary intervention.