Heart Disease 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:

• People aged between 18 and 80 years old (inclusive).
• People who are willing and able to provide written consent to take part.
• Women who are able to become pregnant must agree to use adequate contraception during the trial.
• People with suitable mental and thinking abilities to take part, as assessed by the trial team.
• People whose heart measurements meet specific size requirements — the distance inside the heart and the heart chamber volume must meet minimum thresholds (confirm with trial site).
• People whose body surface area (a measure based on height and weight) is at least 1.2 m².
• People with a weakened heart pump function (ejection fraction of 35% or less) and a heart failure severity rating of 4 or below on a standard medical scale.
• People with advanced heart failure who still have symptoms despite receiving the best available medicines, and who would normally meet standard medical criteria for a surgically implanted heart assist device.
• Additionally, people must meet at least one of the following conditions, as approved by an international expert panel: having a medical reason that makes a standard heart assist device implant too risky (such as certain measurements of heart pressures, or physical or surgical factors — confirm with trial site); having a high risk of serious complications from the external cable that normally passes through the skin with standard devices (for example, due to repeated infections, severe diabetes, a weakened immune system, severe weight loss, or psychological factors affecting the ability to manage such a cable); or being temporarily unable to receive a heart transplant (for example, due to a history of cancer or certain immune system factors — confirm with trial site).
• People who have health insurance coverage, if this is required in the country where the trial is taking place.
• People who already have, or who need to have, a specific type of heart defibrillator device made by Medtronic or Boston Scientific.

Who may not be able to join:

• People with a Body Mass Index (BMI) over 40.
• People whose right-side heart function falls below a certain level, based on a specific heart ultrasound measurement (confirm with trial site).
• People whose heart blood flow measurement falls below a specific threshold on ultrasound (confirm with trial site).
• People who cannot receive a heart transplant due to surgical risks.
• People who currently have another mechanical heart support device in use, other than a specific type of temporary heart pump called an intra-aortic balloon pump.
• People who have previously had surgery on the left side of their chest (left thoracotomy).
• People with a known, untreated bulge in the main artery of the chest or abdomen larger than 5 cm.
• People who have had heart surgery within 30 days before the planned implant date.
• People who have had a heart attack within 14 days before the planned implant date.
• People who have been on a breathing machine for more than 72 hours during the four days just before the planned implant.
• People who have had a blood clot in the lungs within three weeks before the planned implant.
• People who currently have a blood clot in the heart, confirmed by medical imaging.
• People who have had a stroke within 180 days before screening, have significant symptoms of blocked blood vessels to the brain, or have a severe narrowing (more than 80%) of major arteries supplying the brain.
• People with moderate to severe leaking of the aortic heart valve (more than 50% leakage).
• People with moderate to severe narrowing of the aortic heart valve (valve opening of 1.5 cm² or less).
• People with active, uncontrolled infections, or certain abnormal blood or body fluid test results indicating infection or inflammation (confirm with trial site).
• People with uncorrected low platelet counts or blood clotting disorders (confirm with trial site for specific thresholds).
• People with significant liver problems, including a high bilirubin level in the 72 hours before implant, confirmed liver cirrhosis, or high pressure in the liver's blood supply.
• People with severely elevated lung blood pressure that does not respond to medication.
• People who already have a mechanical (artificial) heart valve.
• People whose heart failure is caused by or linked to certain specific conditions such as thyroid disease, a thickened obstructive heart muscle, disease of the sac around the heart, amyloidosis, active heart inflammation, a stiffened heart muscle condition, or a hole between the heart's lower chambers.
• People with severe chronic lung disease (COPD) or severe restrictive lung disease, rated at a certain severity level on a standard medical scale (confirm with trial site).
• People who are currently participating in another clinical trial involving experimental drugs, devices, or biological treatments.
• People with a serious illness other than heart disease that is expected to limit survival to one year or less.
• People with severe circulation problems in the legs or feet, including pain at rest or non-healing sores caused by poor blood flow.
• People who are pregnant.
• People who are unwilling or unable to follow the requirements of the study.
• People who are unable or unwilling to sign the written consent form.
• People for whom the surgeon considers the implant surgery to carry an unacceptably high risk due to technical factors.
• People who cannot tolerate blood-thinning or anti-clotting medications that may be needed before, during, or after the procedure.
• People with significantly elevated specific liver enzyme levels in blood tests taken within 72 hours before the implant (three times the normal upper limit).
• People who live alone without someone available to support them.
• People with a rapid abnormal heart rhythm called atrial fibrillation, unless a specific procedure to manage the heart's electrical pathway has been planned (confirm with trial site).
• People whose heart chamber size falls below a specific measurement threshold on imaging (confirm with trial site).
• People with a high organ failure score (above 8 on a standard medical scoring system).
• People who are minors, people without legal capacity to consent, or people under legal protection.
• People who have participated in another clinical trial within the past 12 months.
• People who already have an implanted heart defibrillator device that is not made by Medtronic or Boston Scientific.

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