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:

• People aged 18 to 75 years old.
• People who have signed a consent form agreeing to take part in the study.
• People with a body surface area (a measure of body size based on height and weight) of at least 1.2 m².
• People with the most severe class of heart failure symptoms, known as NYHA Class IV, meaning the heart is working very poorly even at rest.
• People whose heart's pumping strength (left ventricular ejection fraction) is 25% or less, which is significantly below the normal range.
• People who are already on the best available medicines for heart failure but still meet at least one of the following: they are unable to do any physical activity because of their heart failure; or if exercise testing is possible, their heart and lungs perform very poorly during that test; or their kidneys, liver, or lungs are getting worse because the heart is not pumping enough blood; or they are currently relying on a mechanical heart-assist device (such as an Impella or IABP); or they cannot be taken off medicines that are needed to keep the heart pumping (called inotropes).

Who may not be able to join:

• People whose heart failure could potentially be treated with other available therapies, such as certain types of pacemaker devices.
• People who cannot tolerate blood-thinning or anti-clotting medicines, or other medicines that the trial doctors would require before or after surgery.
• People with known blood-clotting disorders, such as disseminated intravascular coagulation or a serious reaction to the blood-thinning medicine heparin (heparin-induced thrombocytopenia type II).
• People with a low platelet count (the cells that help blood clot), below a certain threshold.
• People with serious psychiatric illness, significant memory or thinking problems, or personal or social circumstances that would make it very difficult to follow the trial's requirements or manage the heart-assist device.
• People for whom surgery would carry an unusually high risk, as judged by the trial doctors.
• People with an active infection that is not under control.
• People with severely reduced liver function, indicated by high bilirubin levels, liver inflammation caused by reduced blood flow, biopsy-confirmed liver scarring (cirrhosis), or a clinical liver severity score in the serious range (Child-Pugh B or C).
• People with severe chronic lung disease (COPD), based on specific breathing test results.
• People with severely elevated pressure in the lungs (pulmonary hypertension) that does not improve with medicines.
• People who have had a stroke in the 180 days before enrolling, or who have a significant narrowing (more than 70%) of a main artery supplying the brain (carotid artery stenosis) with associated symptoms.
• People with severely reduced kidney function or who are currently on dialysis.
• People with serious disease in the blood vessels of the legs or other limbs, causing pain at rest or open sores on the limbs.
• People whose heart failure is caused by or linked to uncorrected thyroid disease, certain structural heart or muscle conditions (such as obstructive or restrictive cardiomyopathy, pericardial disease, amyloidosis, or giant cell myocarditis).
• People with a moderate to severe leaky aortic heart valve that is not planned to be fixed at the time of device implantation.
• People with a known, untreated aneurysm (bulge) in the main abdominal or chest artery larger than 5 cm.
• People with uncontrollable dangerous heart rhythm problems (ventricular tachyarrhythmias or ventricular fibrillation).
• People who had a major heart attack (STEMI) less than 2 weeks before the planned procedure.
• People with signs of serious failure of the right side of the heart, based on specific measurements from heart scans or pressure readings.
• People for whom support to both sides of the heart (Bi-VAD) is planned before entering the trial.
• People who had a cardiac arrest requiring resuscitation in the month before enrollment, and who have not fully recovered their mental and cognitive function.
• People who have previously had any organ transplant.
• People with low levels of certain proteins in the blood (pre-albumin or albumin) that indicate poor nutritional status.
• People with any other serious health condition (besides heart failure) that is likely to limit survival to less than 24 months.
• People who are pregnant (confirmed by a positive pregnancy test), if there is any possibility of pregnancy.
• People who are currently breastfeeding.
• People already participating in another clinical trial that could interfere with this study's results.
• People who have been placed in an institution by a court or government authority.

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