Stroke 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 are 22 years of age or older at the time of signing consent forms
• People who have been assessed by a doctor as appropriate candidates for a planned, non-emergency heart valve replacement procedure done through a blood vessel in the upper leg (known as transfemoral TAVR), on either a natural or previously replaced aortic valve — and whose procedure can be scheduled on a Monday through Thursday due to specialist availability
• People whose heart pumping strength (left ventricular ejection fraction) is at or above 30%, as confirmed by a heart ultrasound taken within the 6 months before the procedure
• People who are willing and able to sign consent and privacy authorisation forms before the study begins
• People who are willing and able to follow the study's required procedures and assessments
• People whose heart ultrasound results confirming adequate heart function are available from within the past 6 months
• People who have had a CT scan of their blood vessels within the past 6 months showing that their anatomy is physically compatible with the study devices, including: a section of the main artery from the heart (ascending aorta) at least 8 cm long; leg and hip artery width of at least 8.0 mm; a specific diameter range in the ascending aorta or aortic arch (25–40 mm); only minimal fatty buildup or calcium deposits in those arteries; artery sizes in the neck and chest region within specific ranges required for device placement; less than 70% narrowing in key neck arteries; no significant narrowing, ballooning, tearing, or aneurysm near certain artery openings; adequate blood flow to the right arm; and blood vessels without excessive twisting or curving (confirm with trial site for full anatomical details)

Who may not be able to join:

• People whose heart valve procedure requires a balloon-expandable type of replacement valve (rather than a self-expanding one)
• People who have had a stroke or mini-stroke (TIA) in the past 6 months, or who have had any prior stroke that left a lasting significant disability
• People whose heart pumping strength is below 30%, or who have had a state of heart shock, or who have needed medications or mechanical devices to support their heart function within the past 3 months
• People who have had a heart attack within the past 30 days before the planned procedure
• People who are planned to have another heart surgery or heart procedure at the same time as, or within 30 days before, the valve procedure (note: needing a pacemaker after the valve procedure does not disqualify someone)
• People with serious kidney problems, specifically a kidney function measurement (eGFR) below 30 mL/min
• People with a blood-clotting disorder that cannot be managed with standard blood-thinning medication during the procedure
• People with a known allergy, intolerance, or medical reason to avoid any of the medications used in the study, including heparin, aspirin, clopidogrel, contrast dye, or anaesthesia — unless the reaction can be adequately managed beforehand
• People currently receiving clot-dissolving (thrombolysis) treatment
• People with a history of serious bleeding disorders or significant problems with blood clotting
• People with severe liver failure (classified as Child-Pugh class C)
• People with an active heart infection or ongoing body-wide infection, indicated by high fever or elevated white blood cell count
• People with a known allergy to materials used in the EmStop device, such as nitinol (a type of metal alloy)
• People who are currently taking part in another clinical trial involving a drug or medical device
• People who are known or suspected to be pregnant, or who are breastfeeding; women of childbearing potential must have a negative pregnancy test within 48 hours before the procedure
• People who belong to vulnerable populations, such as those who are incarcerated or who have significant cognitive impairment
• People whom the study investigators determine, for any other clinical reason, are not suitable candidates for the study

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