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 who are 18 years of age or older.
• People who have been approved by their hospital to receive a left ventricular assist device (LVAD), which is a mechanical pump that helps the heart work.
• People whose body surface area (a measure based on height and weight) is at least 1.2 m².
• People with severe heart failure that has not responded to advanced treatment, either causing symptoms during minimal activity or at rest.
• People whose heart is pumping at 25% or less of its normal capacity (or less than 30% while on heart-supporting medications or devices).
• People whose heart cannot maintain enough blood flow on its own, and who either depend on medications to keep the heart pumping, or have very low heart output without those medications, AND who also meet at least one of the following: they have been on the best available heart failure treatment for at least 45 of the last 60 days without improvement or without being able to tolerate it; OR they have had advanced heart failure for at least 14 days and have been dependent on a temporary heart-support device for at least 7 of those days.
• People who have given their voluntary and informed consent to participate.
• Women who could become pregnant must agree to use effective contraception and must have a negative pregnancy test before joining.

Who may not be able to join:

• People whose heart failure is caused by certain specific conditions, such as a thickened or stiff heart muscle, a protein build-up in the heart, complex heart defects present from birth, uncorrected thyroid problems, or disease affecting the sac around the heart.
• People who had a heart attack within 7 days before enrolling in the study.
• People who had chest or heart surgery within 30 days before the planned device implant, unless that surgery was to place a specific type of temporary heart-support device (Impella 5.5, Impella CP, or TandemHeart).
• People whose overall health or other medical conditions make surgery very high risk, as determined by the study doctor.
• People who cannot take warfarin, a blood-thinning medication.
• People with known problems where their blood clots too much or too little, or who have had a specific serious reaction to heparin (a blood thinner), or who need an alternative blood-thinning approach during heart-lung bypass surgery (confirm with trial site).
• People who already have a long-term mechanical heart-support device in place.
• People who are expected to need a long-term or temporary right-side heart-support device at the same time as the LVAD is placed.
• People currently using a temporary heart-support device other than specific approved types (intra-aortic balloon pump, Impella 5.5, Impella CP, or TandemHeart).
• People currently on a temporary heart-support device who also have certain abnormal blood test results suggesting the device may be causing red blood cell damage (confirm with trial site).
• People who have previously had an organ transplant.
• People who have a mechanical heart valve in the aortic position that cannot be changed to a tissue valve at the time of the LVAD procedure.
• People with a very low platelet count (a blood component needed for clotting) below a specific level.
• People with a known, untreated bulge in the main abdominal artery (aorta) larger than 5 cm.
• People with a moderately or severely leaky aortic heart valve that cannot be repaired during the LVAD procedure.
• People with an active, uncontrolled infection anywhere in the body.
• People who have tested positive for COVID-19 within 21 days of enrolling and who also needed extra oxygen or had a specific high blood marker of inflammation.
• People with severe damage to one or more major organs, including: severely abnormal liver function or cirrhosis; severely abnormal blood-clotting results not caused by blood-thinning medication; severely reduced kidney function or dependence on dialysis; severely high blood pressure in the lung arteries that does not respond to medication; severe lung disease requiring home oxygen or with very low lung function test results; dependence on a breathing machine for more than 3 days at the time of enrolment; a blood clot in the lungs within the past 60 days; a stroke within the past 90 days, or a previous stroke that has left significant disability; symptomatic disease affecting blood vessels in the brain, or a severely narrowed neck artery (more than 80% blocked); significant circulation problems in the limbs causing pain at rest or open sores; or very low protein levels in the blood indicating poor nutrition.
• People who have another serious non-heart illness that is likely to limit their survival to less than two years.
• People with a serious psychiatric condition, irreversible memory or thinking problems, inadequate social support, or a history of not following medical instructions, in a way that is likely to affect their ability to participate reliably in the study.
• People who are already taking part in another interventional clinical trial that could affect or interfere with the results of this study.

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