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 years or older.
• People who are willing and able to give formal consent to take part, attend follow-up visits, and follow the study instructions.
• People who have been diagnosed with heart failure for more than 90 days, have been on the best tolerated medical treatment for at least 30 days as recommended by heart failure guidelines, and meet one of the following three sets of conditions:
  • People with moderate heart failure symptoms (NYHA Class II) who have had a heart failure-related hospital stay, day-care treatment, or an unplanned visit for intravenous water tablets in the past 12 months, and whose blood test shows a specific heart stress marker (NT-proBNP) at or above a certain level (higher thresholds apply for people with an irregular heart rhythm called atrial fibrillation or flutter) (confirm with trial site); or
  • People with moderately severe heart failure symptoms (NYHA Class III) who have had a heart failure-related hospital stay, day-care treatment, or an unplanned visit for intravenous water tablets in the past 12 months, and whose NT-proBNP blood marker is at or above a certain level (higher thresholds apply for people with atrial fibrillation or flutter) (confirm with trial site); or
  • People with moderately severe heart failure symptoms (NYHA Class III) whose NT-proBNP blood marker is at or above a certain level, even without a recent hospital visit (higher thresholds apply for people with atrial fibrillation or flutter) (confirm with trial site).
• People who have been prescribed a daily water tablet (loop diuretic) dose of at least 40mg of furosemide, or an equivalent dose of another water tablet, for the two weeks before the screening visit.
• People whose daily water tablet dose is able to be increased by at least one and a half times their current dose.
• People whose large abdominal vein (the inferior vena cava, or IVC) measures between 14mm and 28mm wide in the area where the sensor would be placed.
• People whose large abdominal vein has a suitable length of at least 60mm in the placement area.
• People who have reliable mobile or Wi-Fi internet access at home and can use it on a phone or computer.

Who may not be able to join:

• People with very advanced or end-stage heart failure, including those with the most severe ongoing symptoms (NYHA Class IV), those currently receiving intravenous medications to support heart function, those who have received or are expected to receive a heart pump device or heart transplant within the next 6 months, or those receiving end-of-life heart failure care.
• People with severe disease of the heart valves on the right side of the heart, or who have a mechanical valve on the right side of the heart.
• People with an abdominal measurement greater than 143cm (about 56 inches) at the time of screening.
• People whose kidneys are working at a significantly reduced level (eGFR below 25), or who are receiving kidney filtration treatment or regular dialysis.
• People with certain advanced heart muscle diseases, including end-stage hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericardial disease, cardiac amyloidosis, or other conditions where substances build up in the heart muscle (such as hemochromatosis or sarcoidosis).
• People with significant congenital (present from birth) heart conditions that could make it difficult to place the sensor or interpret its readings (confirm with trial site).
• People who have had a major heart or stroke-related event — such as unstable chest pain, a certain type of heart attack, a heart procedure, open heart surgery, or stroke — within the 90 days before giving consent.
• People who have had certain heart devices implanted — including cardiac resynchronisation therapy devices (CRT-P or CRT-D), cardiac contractility modulation devices (CCM), or implantable nerve-stimulation devices used for heart failure — within the 90 days before giving consent.
• People who already have, or are planning to have, a pulmonary artery pressure monitoring device implanted.
• People who are pregnant, breastfeeding, or planning a pregnancy within one year of screening.
• People whose life expectancy is estimated to be less than 12 months due to another illness or the severity of their heart failure.
• People whose anatomy or health conditions, in the opinion of the treating doctor running the trial, would prevent safe implantation or use of the sensor.
• People currently participating in, or planning to participate in, another clinical trial during this study period, unless the trial sponsor has given prior approval.
• People with an active infection anywhere in the body at the time of screening.
• People with a known allergy or sensitivity to antiplatelet medications, contrast dye used in imaging, or any materials used in the sensor (including Nitinol, Polyurethane, Nylon, Polyethylene Terephthalate, or Gold) that cannot be managed using the trial site's allergy management procedures.
• People who are unable to take two antiplatelet medications together for at least 30 days after the sensor is implanted, or who are unable to continue blood-thinning medication if it has already been prescribed.
• People who have an existing filter in their large abdominal vein (IVC), an abnormal or absent IVC or groin vein, a known birth-related abnormality of the IVC, or a blood clot in the IVC, iliac, or common groin veins.
• People who have procedures planned that require access through a vein in the groin within 3 months of the sensor being implanted.
• People who have had a blood clot in the lungs or veins in the 6 months before screening, or who have an ongoing condition that increases the risk of blood clotting (such as thrombophilia).

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