The ELEVATE III Pivotal Study is testing a special device, called the Elevate™ percutaneous Left Ventricular Assist Device System, for patients with serious heart artery issues. This device helps support the heart for up to 6 hours during high-risk surgeries on heart arteries. These surgeries are done to open blocked arteries in a procedure known as High-Risk Percutaneous Coronary Intervention (HR-PCI). The device can help keep the heart stable during the surgery. To join this study, your heart procedure should be planned and agreed upon by both a heart doctor and a heart surgeon.
- The study involves a temporary device that supports the heart for a maximum of 6 hours.
- Participants must have planned high-risk heart procedures and give consent.
- People with certain health conditions, like severe heart failure or recent strokes, cannot join.