Heart Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who weigh at least 20 kg (44 lbs)
- People who have a failing or poorly functioning conduit or previously implanted valve in the pulmonary (right side of the heart) position that needs treatment, and whose anatomy falls within the size range required by the device
- People who have at least a moderate level of a leaky pulmonary valve and/or significant blockage of blood flow through the right side of the heart
- People who have been fully informed about the study and have given written consent to participate (or had a legal representative do so on their behalf)
Who may not be able to join:
- People who currently have an active infection requiring antibiotic treatment (though eligibility may be reconsidered two weeks after finishing antibiotics)
- People who have had or currently have an infection of the heart (endocarditis) within the past 180 days
- People with low white blood cell counts, low red blood cell counts, low platelet counts, or any known blood clotting disorder
- People whose anatomy is not suitable for the device to be delivered through the groin (femoral) blood vessel
- People who need other heart procedures done at the same time, except for certain procedures on the pulmonary arteries
- People whose imaging shows that placing the new valve could squeeze or compress the coronary arteries (blood vessels supplying the heart)
- People who have had a heart-related procedure or surgery within the 30 days before this procedure
- People who have any surgery or heart-related procedure planned within 30 days after this procedure
- People with a current or past history of intravenous drug use
- People with a serious non-heart-related illness where life expectancy is less than one year
- People with a known allergy to aspirin or heparin who cannot safely take alternative blood-thinning medications
- People with a known allergy to cobalt-chromium, nickel, or contrast dye used in imaging, if that allergy cannot be adequately managed beforehand
- People currently enrolled in another clinical trial that has not yet completed its main study goals
- People who are pregnant or currently breastfeeding
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: D. Scott Lim, MD, University of Virginia Medical Center
Phone: (949) 250-2500
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
THV dysfunction
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.