Pulmonary Hypertension 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:

Criteria that apply to all groups:

• Adults aged 18 or older.
• People whose tests show the average blood pressure in the main lung artery is above a certain level (above 25 mmHg).
• People whose heart tests show the right side of the heart is not pumping as well as it should, based on at least one of several specific measurements (confirm with trial site for exact measurements).
• People whose lungs show reduced ability to adjust to changes in blood flow, based on a specific measurement (confirm with trial site).
• People whose pulmonary hypertension symptoms are classified by their doctor as moderately or severely limiting daily activity (WHO Functional Class III or ambulatory IV).
• People whose main lung artery is the right size and shape for the device to be placed, as confirmed by a special type of CT scan.
• People whose care team at the trial site and an independent review committee have decided the Aria CV device is appropriate for them.
• People who have signed a consent form agreeing to take part in the study.
• People who agree to follow any travel restrictions related to the device.

Additional criteria for people with WHO Group I pulmonary hypertension:

• People whose heart pressure measurements show a specific reading at or below 15 mmHg in the lung capillaries.
• People whose lung blood vessel resistance is above a certain level (more than 3 Woods Units).
• People who are still experiencing symptoms despite being on a stable, appropriate pulmonary hypertension medication regimen for at least 90 days before the procedure.

Additional criteria for people with WHO Group II pulmonary hypertension (heart failure with preserved pumping function):

• People who have been diagnosed with heart failure where the heart still pumps at least 50% of its blood with each beat.
• People whose lung capillary pressure is above 15 mmHg.
• People whose lung blood vessel resistance is above 3 Woods Units.

Additional criteria for people with WHO Group III pulmonary hypertension (lung disease related):

• People who have been diagnosed with a lung disease such as COPD, interstitial lung disease, idiopathic pulmonary fibrosis, or a combination of emphysema and fibrosis.
• People whose lung capillary pressure is at or below 15 mmHg.
• People whose lung blood vessel resistance is above 4 Woods Units.

Who may not be able to join:

Criteria that apply to all groups:

• People diagnosed with WHO Group 4 or Group 5 pulmonary hypertension.
• People who have had a heart attack or stroke within the 6 months before the procedure.
• People who have had a documented, sustained rapid heart rate (above 110 beats per minute) within 2 months before the procedure.
• People with uncontrolled, ongoing irregular heart rhythm (atrial fibrillation).
• People who require urgent heart surgery or already have a heart device implanted that may interfere with the Aria CV device (as determined by the investigator).
• People with a history of infection of the heart lining (endocarditis).
• People with a history of blood clots in the lungs that occurred without an obvious cause (unprovoked pulmonary embolism).
• People with severely reduced kidney function or kidney failure requiring regular dialysis.
• People with the connective tissue disease scleroderma who also have a history of gastrointestinal bleeding or iron infusions within the past 2 years, significant skin involvement affecting daily activities or the ability to receive intravenous medication, or skin sores and ulcers on the fingers or body.
• People who have recently taken certain immune-suppressing medications, including Mycophenolate mofetil within the past 30 days, Rituximab within the past 6 months, Prednisone at a dose above 12 mg per day at the time of enrolment, or any other immune-suppressing medication not listed here.
• People with certain rare lung blood vessel conditions (pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis).
• People with a known significant hole between the chambers of the heart (such as a patent foramen ovale or similar structural abnormality).
• People with a history of certain types of bleeding (stomach vessel abnormalities, gastrointestinal bleeding, or bleeding in the brain) that the investigator believes would put them at serious risk when combined with the blood-thinning medication required after the device is placed.
• People with an active infection requiring antibiotic treatment within 2 weeks of the procedure.
• People with blood disorders that the investigator believes would create unacceptable risks during the procedure, such as severely low white blood cells, anaemia, low platelets, untreated iron deficiency, or a history of abnormal bleeding or clotting.
• People whose anatomy is not suitable for device placement.
• People with moderate to severe leaking of the pulmonary heart valve, or severe leaking of the tricuspid heart valve.
• People who are allergic or have a medical reason they cannot take required medications (such as contrast dye, warfarin, or heparin) and where this cannot be safely managed.
• People who are allergic to materials in the device, including polyurethane, silicone, nickel, or titanium.
• People who are not eligible for, or who refuse, a blood transfusion.
• People who are pregnant, breastfeeding, or planning to become pregnant within the next two years.
• People whose life expectancy is less than two years.
• People currently enrolled in, or planning to join, another research study that may affect the results of this trial.
• People using supplemental oxygen whose treatment routine, in the doctor's opinion, does not support their safety in this trial (confirm with trial site).
• People who have been diagnosed with a heart condition called cardiac amyloidosis.

Additional exclusion criteria for WHO Group II only:

• People diagnosed with a specific type of thickened heart muscle condition that blocks blood flow (hypertrophic obstructive cardiomyopathy / IHSS).
• People with untreated severe narrowing of the aortic or mitral heart valves.
• People diagnosed with heart failure where the heart's pumping function is significantly reduced.
• People diagnosed with non-obstructive hypertrophic cardiomyopathy (a thickened heart muscle condition that does not block blood flow).

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