Pulmonary Hypertension Trial, Recruiting

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

Who might be able to join this trial:

• You have signed a consent form agreeing to take part in the study before any study procedures begin.
• Your heart is pumping weakly (less than 30% of normal) and not moving enough blood through your body efficiently.
• You have significant difficulty with physical activity — either you can walk 350 metres or less in 6 minutes due to heart failure, or your heart and lungs are not able to use oxygen well enough during exercise.
• Your heart failure symptoms are severe (classified as NYHA Class IIIB or Class IV, meaning you feel very limited or unwell even at rest or with minimal activity) (confirm with trial site).
• You have been hospitalised for heart failure at least once in the past 12 months.
• You already have a small wireless pressure sensor (called a CardioMEMS device) implanted in your lung artery, or you are willing to have one implanted.
• If assigned to the device group, you are willing and able to receive a heart pump called the HeartMate 3 (HM3).

Who may not be able to join:

• You are under 18 years of age.
• You have needed heart-strengthening medication given through a drip (IV inotropes) in the last 30 days.
• You have a medical reason that makes it unsafe for you to receive the HeartMate 3 heart pump or the CardioMEMS sensor device.
• Your heart failure is caused by certain specific conditions such as thyroid disease (untreated), a thickened or stiff heart muscle from amyloidosis, a scarred heart lining (pericardial disease), or certain other specific heart conditions.
• Your anatomy or physical condition makes surgery to implant the heart pump or sensor too risky, in the surgeon's judgement.
• You are already using a mechanical device to support your heart.
• You have a mechanical heart valve in the aortic position that cannot be replaced or adjusted at the time of heart pump surgery.
• You have previously received a solid organ transplant (such as a kidney, liver, or lung).
• You have a psychiatric illness, significant memory or thinking problems, or personal/social circumstances that would make it difficult to follow the study requirements and manage the heart pump.
• You have an active infection that is not under control.
• You have a complex congenital (present from birth) heart condition.
• You are currently pregnant, or could become pregnant and are not willing to use contraception while using the heart pump.
• You have had a blood clot in your lungs (pulmonary embolism) in the last 30 days, or you have a history of more than one episode of blood clots in your lungs or legs.
• A heart pump or two-sided heart pump support is already planned for you before joining the study.
• You have serious problems with other organs, including any of the following: your blood does not clot properly (not due to blood-thinning medication); your kidneys are functioning very poorly and are not responding to water tablets or you are on dialysis; you have a scarred liver (cirrhosis confirmed by biopsy); you need ongoing dialysis; you have severe lung disease (COPD) where your lung function is below 30% of expected; you have a serious narrowing (over 80%) in a main artery supplying your brain; or you have severe blood vessel disease in your limbs causing pain at rest or open sores.
• You have another serious illness (not related to heart failure) that may mean you would not survive beyond 2 years.
• You are currently taking part in another clinical trial with an active treatment that could interfere with this study's results.

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