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 whose heart failure symptoms fall into a moderate category (NYHA Class II or III) and who are already on the best available standard heart failure medications
• People whose heart's electrical signal width (QRS duration) is 130 milliseconds or less
• People whose heart pumps out 40% or less of its blood with each beat (known as ejection fraction)

Who may not be able to join:

• People whose 6-minute walking test result is either above 500 metres or below 200 metres
• People whose blood level of a heart stress marker (NT-proBNP) is too low — either below 250 if taking water tablets (loop diuretics), or below 500 if not taking them
• People whose resting heart rate while lying down is above 140 beats per minute
• People whose resting blood pressure (top number) is below 80 or above 170 mmHg
• People whose kidney function marker (serum creatinine) is above a certain level, suggesting reduced kidney function
• People whose liver function test results are more than three times the upper limit of the normal range
• People who, in the past 3 months, have had unstable chest pain, a heart attack, heart bypass surgery, a stenting procedure, a stroke or mini-stroke, a prolonged irregular heart rhythm lasting more than 24 hours, dangerous fast heart rhythms, or an electrical shock to reset the heart rhythm
• People who have received medications to help the heart pump (inotropic drugs) in the past 3 months
• People who have a very slow heart rate (below 50 beats per minute), fast irregular heart rhythms above 100 beats per minute, sustained fast ventricular rhythms, or frequent abnormal heartbeats making up more than 10% of beats at the time of screening
• People who have had significant uncontrolled slow or irregular heart rhythms, unstable fast heart rhythms, or frequent abnormal heartbeats making up more than 10% of beats in the past 3 months
• People whose weakened heart muscle has a reversible, non-blockage-related cause
• People who have significant valve disease in the heart, or who are expected to need heart valve surgery within the next 12 months (the trial site cardiologist assesses specific valve conditions across the mitral, tricuspid, aortic, and pulmonary valves)
• People with severe primary lung disease, including a condition causing high blood pressure in the lung's arteries, with lung artery pressure above 70 mmHg at rest
• People with severe chronic lung disease (such as COPD) or other lung conditions where breathing capacity is less than 50% of expected
• People with more than a small fluid collection around the lungs, or who have had fluid drained from around the lungs in the past 6 months
• People with a known or suspected paralysed diaphragm (the muscle below the lungs used for breathing), including where a chest X-ray shows the diaphragm sitting unusually high
• People with disease affecting the sac around the heart (pericardial disease)
• People with nerve damage related to diabetes (diabetic neuropathy)
• People who already have a device in place that electrically stimulates the diaphragm to assist breathing
• People who currently have, or have had within the past 3 months, certain implanted heart devices — including a left ventricular assist device (LVAD), baroreflex activation therapy device, cardiac contractility modulation device, inter-atrial shunt device, or temporary mechanical heart support — or people who have a cardiac resynchronisation therapy (CRT) device that is functioning
• People for whom keyhole (laparoscopic) surgery to access the diaphragm is not considered safe, as determined by the implanting doctor
• People with known conditions inside the abdomen that could increase the risks of keyhole surgery to access the diaphragm
• People who have had open abdominal surgery within the past year
• People who have previously had a chest or abdominal organ transplant
• People currently taking medications that suppress the immune system
• People with a body mass index (BMI) above 40
• People currently enrolled in another clinical investigation or trial
• People whose life expectancy is less than one year due to any condition
• People who are pregnant or planning to become pregnant during the study period
• People with known allergies to the materials used in implantable devices
• People who have needed intravenous (IV) antibiotics for a widespread infection within the past 3 months

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