Testing personalized heart device implants for heart failure

Plain-English translation of NCT06055504 on ClinicalTrials.gov ↗ · Source last updated February 2024 · Translation generated July 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 doctors can use genetic testing and specialized heart imaging to more carefully decide which patients with a type of heart weakness called non-ischemic dilated cardiomyopathy actually need an implantable cardioverter defibrillator (ICD)—a small device that helps prevent dangerous heart rhythms. Some patients currently receive this device based on standard guidelines, but this study asks whether a more personalized approach using genetic information and imaging results could be just as safe while avoiding unnecessary surgery for those who truly don't need it.

Many patients with this heart condition receive protective devices as a precaution, but not all of them will ever have a dangerous heart rhythm. This trial exists to see whether genetic and imaging tests can identify which patients really need the device and which ones could safely avoid surgery, making treatment more tailored to each person's actual risk.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with non-ischemic dilated cardiomyopathy
you have a weakened heart with an ejection fraction of 35% or lower
you have been on optimized heart medications at the highest tolerated doses for at least 3 months
you have a life expectancy of at least 12 months

You likely don't qualify if…

you have a history of heart attacks or significant blockages in your coronary arteries
your heart weakness is due to congenital heart disease, valve disease, alcohol use, or chemotherapy
you have a history of survived sudden cardiac death or dangerous heart rhythms requiring treatment
you are in the most severe functional class (NYHA class IV) of heart failure symptoms
you have received an organ transplant or are waiting for emergency transplantation

What participation looks like

If you qualify, you will be randomly assigned to one of two groups. One group will receive a standard implantable cardioverter defibrillator device. The other group will have genetic testing and specialized heart imaging performed first; depending on those results, you may or may not receive the device. All participants will be followed over time to see how well they do, whether they experience dangerous heart rhythms, and whether the personalized approach works as well as the standard approach.

AI-generated summary from trial data · Jul 1, 2026 · Not medical advice

Trial locations(31 sites)

Spain

H.C.U de Santiago de Compostela, Santiago de Compostela, A Coruña

H.U. de Bellvitge, L'Hospitalet de Llobregat, Barcelona

Hospital Parc Taulí, Sabadell, Barcelona

H.U. A Coruña, A Coruña, La Coruña

H.U. Puerta de Hierro, Majadahonda, Madrid