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 who have been in cardiogenic shock (a serious condition where the heart cannot pump enough blood) for less than 24 hours.
• People whose heart's pumping strength falls within a specific range — confirmed by an ultrasound of the heart on the day of enrolment (confirm with trial site for exact values).
• People who have no more than mild dysfunction of the right side of their heart, as confirmed by a heart ultrasound on the day of enrolment.
• People who have given their signed agreement to participate.

Who may not be able to join:

• People whose shock is caused by something other than the heart — such as severe blood loss, infection, a blood clot in the lungs, or a severe allergic reaction.
• People whose blood oxygen levels are too low at the time the device would be placed, and cannot be improved with oxygen or a breathing tube.
• People who are experiencing a sustained abnormal heart rhythm called ventricular tachycardia at the time of enrolment.
• People with significant failure or dysfunction of the right side of the heart.
• People who are awake but unable to lie still due to agitation or lack of cooperation.
• People with a specific heart muscle condition called hypertrophic obstructive cardiomyopathy.
• People who have a blood clot inside the left chamber of the heart.
• People who already have an intra-aortic balloon pump (a type of heart support device) in place.
• People who have an artificial mitral or aortic heart valve, or more than mild narrowing of those natural valves.
• People with a significant leaking of the aortic heart valve (rated 2 or higher on a 4-point scale).
• People with certain structural complications from a heart attack, such as a tear between heart chambers, or an uncorrected hole in the heart.
• People with confirmed or suspected brain damage (for example, from lack of oxygen).
• People who have had a stroke or mini-stroke within the past 3 months.
• People with blood clotting problems that cannot be corrected, or who have active uncontrolled bleeding.
• People with a known allergy, sensitivity, or intolerance to heparin (including a specific heparin-related blood condition), aspirin, certain blood-thinning medications, or contrast dye used in imaging.
• People with a known allergy, sensitivity, or intolerance to nickel.
• People with known or suspected severe lung disease.
• People with blood vessel disease that would make it unsafe to place the device (confirm with trial site).
• People with aortic conditions such as aneurysms, extreme bending of the aorta, or heavy calcification that could make device placement unsafe.
• People with any known or suspected condition that causes fragile red blood cells or breakdown of blood cells.
• People currently participating in another trial of an investigational drug or device (participation in post-market registries may be considered — confirm with trial site).
• People with other serious health conditions giving them a life expectancy of less than one year.

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