Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People with end-stage heart failure, as assessed by a local heart specialist team, where the heart's pumping ability (measured by a scan) is at or below 35%, confirmed within one week before joining the trial
• People whose heart is not pumping enough blood to the body, or who have very limited exercise capacity, or who have been hospitalised for heart failure at least twice in the past year (confirmed within one month before joining)
• People whose heart failure symptoms are classified as moderately severe to severe (a clinical scale called NYHA class III or IV, corresponding to INTERMACS profile 4–6)
• People who have been taking the maximum tolerated doses of recommended heart failure medications — including beta-blockers, certain blood pressure medicines, and a type of diabetes/heart drug called an SGLT2 inhibitor — for at least 45 days (if those medications are appropriate for them)
• People who have already had a heart device implanted (such as a device to help the heart beat in rhythm, or one that corrects dangerous heart rhythms), if that was recommended for them, and have had it in place for at least 45 days
• People who have not required a heart pump machine or drugs to support the heart for more than 30 days
• People who have health insurance or equivalent health coverage
• People who have given signed written consent to participate
• People who are not under any legal protection order (confirm with trial site)

Who may not be able to join:

• People who currently depend on drugs to stimulate the heart, or who have had a mechanical heart support device in place within the last 30 days
• People whose right side of the heart is also severely weakened, where the heart team believes a two-sided mechanical heart support device would be needed
• People who are currently pregnant, or women of childbearing age who are not using contraception
• People who currently have an active infection
• People who already have permanent damage to major organs (such as the kidneys or liver) before any device is implanted
• People who cannot take blood-thinning or anti-clotting medications
• People who have previously had any organ transplant
• People with a psychiatric condition, lasting cognitive (thinking or memory) difficulties, or significant psychosocial problems that could make it hard to follow the trial requirements
• People whom the heart specialist team considers to be frail
• People with a low blood platelet count (below 100,000 per millilitre)
• People with a smaller body surface area than 1.2 m² (a measure of body size) (confirm with trial site)
• People with another serious medical condition, unrelated to heart failure, that would likely limit survival to less than 24 months
• People with severely reduced kidney function or liver cirrhosis
• People who are already taking part in another interventional clinical trial

Important: Always verify eligibility with the trial site directly before applying.