Heart Support Device During High-Risk Heart Artery Procedures

Plain-English translation of NCT07149714 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated August 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a temporary heart support device called the iVAC 2L to help patients with severe coronary artery disease undergo a risky heart artery procedure called percutaneous coronary intervention (PCI). The device pumps blood from your heart during and shortly after the procedure to keep you stable and reduce the risk of heart failure or other serious complications.

Currently, many patients with severe coronary artery disease who are too sick or high-risk for open-heart surgery have limited options. This trial exists to see if using temporary mechanical heart support during the procedure can make this less-risky procedure safer and more effective for these vulnerable patients.

Do you qualify?

You likely qualify if…

you have been diagnosed with severe coronary artery disease requiring a high-risk heart artery procedure, as agreed by your heart team
you are able and willing to give informed consent to participate
you have adequate blood vessel size in your groin area (at least 6mm diameter) to allow device placement
you do not have significant right-sided heart failure or a blood clot in your heart

You likely don't qualify if…

you have severe peripheral artery disease that would prevent safe device placement
you have a mechanical heart valve or significant aortic valve disease
you have had a major bleeding event or stroke within the past 3 months
you have serious liver or kidney failure, active cancer, or other major health conditions that could affect your safety
you have a septal defect, heart rupture, or cardiac tamponade

What participation looks like

You will be admitted to the hospital where your heart team will evaluate your condition with heart imaging, blood tests, and risk assessment. Then you will be taken to a special operating room where doctors will place the iVAC 2L device through a small catheter in your groin artery, positioning it to support your heart during your coronary procedure. The device will be removed shortly after the procedure once your heart is stable enough.

Heart Support Device During High-Risk Heart Artery Procedures

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)