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 or older who have given written consent to participate
• People living with long-term heart failure that causes symptoms, rated at a certain level of severity (NYHA Class 2 or above)
• People whose left side of the heart shows higher pressure than the right side, with a pressure difference of at least 5 mmHg (confirmed by heart pressure measurements)
• People whose heart pumping function (left ventricular ejection fraction) is at or above 15%, with an additional blood test result requirement for those whose pumping function is above 40%
• People who have been on a stable, guideline-based heart failure treatment plan for at least one month before joining the trial

Who may not be able to join:

• People with a life expectancy of less than one year, those with the most advanced stage of heart failure (Stage D), or those already on a heart transplant waiting list
• People with serious right-side heart problems, including severely reduced right heart function, significant enlargement of the right heart chamber, or severely high blood pressure in the lungs (confirm with trial site for exact measurements)
• People whose heart ultrasound (echocardiogram) shows a mass, blood clot, or infection growth inside the heart
• People with high blood pressure that is not well controlled by medication (systolic above 160 mmHg or diastolic at or above 100 mmHg) at the time of screening
• People with an irregular heart rhythm (atrial fibrillation) that is not controlled by medication, with a resting heart rate above 110 beats per minute
• People with a documented history of specific types of heart muscle disease (such as obstructive hypertrophic, restrictive, or infiltrative cardiomyopathy) or disease of the sac surrounding the heart
• People with a heart defect present from birth that would interfere with placing the trial device, as judged by the investigator
• People who have previously had a procedure or surgery to close a hole in the wall between the heart's upper chambers, if this would interfere with device placement
• People who currently have a hole in the wall between the heart's upper chambers, or certain structural features of that wall (such as thickness over 10 mm or an aneurysm) that would prevent the device from being placed correctly
• People with significant heart valve problems, including moderate-to-severe leaking or severe narrowing of certain heart valves
• People with a prior diagnosis of primary pulmonary hypertension (high blood pressure in the lungs not caused by another condition)
• People with severe chronic lung disease (COPD) that requires regular steroid tablets or ongoing oxygen use
• People who have had a stroke, mini-stroke (TIA), blood clot in a vein (DVT), or a blood clot in the lungs within the past 6 months; or anyone with lasting disability from a previous stroke, any prior bleeding in the brain, a known brain aneurysm, or other brain conditions that raise bleeding risk
• People who have had a heart attack or who have a heart condition requiring a coronary procedure or bypass surgery, or who had such a procedure within the past 2 months
• People who have had an implantable defibrillator (ICD) or a right-sided pacemaker fitted within the past 2 months
• People with a significant blood clotting disorder, as determined by the investigator
• People who have had a serious infection (local or throughout the body) requiring antibiotic treatment within the two months before enrolling
• People with advanced kidney disease currently being treated with dialysis
• People with an allergy to nickel and/or titanium (the materials used in the device), if the allergy cannot be medically managed
• People with an allergy to blood-thinning or anti-clotting medications
• People already taking part in another clinical trial that could affect this study's results, as judged by the investigator
• People with other significant health conditions that the investigator considers would make participation unsuitable

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