The VITALYST Early Feasibility Study is a research project to test a device called the VITALYST System. This device helps support the heart during a procedure known as high-risk percutaneous coronary intervention (HR-PCI). HR-PCI is a non-emergency procedure used to open blocked heart arteries. The study will see if the VITALYST System is safe and if it works well.
Eligibility for the study includes being between 18 and 89 years old, needing HR-PCI, and having specific heart conditions. People who have had recent heart attacks, certain heart diseases, or other health issues cannot participate.
- Participants will need to give informed consent and should discuss their suitability with a heart team, including a cardiac surgeon.
- Participants must not have had any major heart issues, like a heart attack or cardiac arrest, in the recent past.
- Participation involves being part of a single-arm study, meaning everyone gets the same treatment without comparison to another group.
Before joining, consider discussing with your doctor about any risks and how the study might benefit your heart health.
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