Recruiting

Heart pump device versus maximum medical therapy for advanced heart failure

Plain-English translation of NCT04768322 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 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 whether a Left Ventricular Assist Device (LVAD)—a mechanical pump that helps your heart pump blood—works better than taking the strongest heart failure medications available. The study will enroll 92 people with end-stage heart failure who are still very sick despite being on maximum doses of heart medications. Researchers want to know if getting this device early, in addition to continuing your medicines, helps you feel better and live longer than staying on medications alone.

Many people with advanced heart failure remain severely ill and keep getting hospitalized even when taking all the strongest medications doctors can give them. There isn't much evidence yet about whether getting a heart pump device early in the disease helps these patients, so this study aims to find out if the device offers real benefits over continuing medical treatment alone.

Do you qualify?

You likely qualify if…

you are at least 18 years old and diagnosed with end-stage heart failure by a heart specialist team
your heart's pumping function (ejection fraction) is 35% or lower within the past week
you have severe symptoms (NYHA class III or IV) despite being on maximum tolerated doses of heart failure medications for at least 45 days
you have been hospitalized for heart failure at least twice in the past year, or have objective signs of poor heart function such as a low exercise capacity
you are not currently dependent on intravenous medications (inotropes) to keep your heart working

You likely don't qualify if…

you have received intravenous heart-strengthening medications or mechanical support in the past 30 days
you have severe dysfunction of your right heart chamber or would need a double pump device
you are pregnant or a woman of childbearing age not using reliable contraception
you have an active infection, end-organ damage, or a condition other than heart failure that would limit your survival to less than 24 months
you cannot take blood-thinning or antiplatelet medications, or you have a bleeding disorder

What participation looks like

If you are randomly assigned to receive the heart pump device, you will have surgery to implant it within 21 days and continue taking your heart medications. If you are assigned to the medication group, you will continue taking the same maximum-dose heart failure medicines you are already on. Both groups will be monitored by the research team to track how you are doing, how often you need hospital visits, and how the treatment affects your symptoms and quality of life.

Heart pump device versus maximum medical therapy for advanced heart failure

What is this trial?

Do you qualify?

What participation looks like

Trial locations(8 sites)