Dissolving plug for outlet ventricular septal defect
Part of Genetic & congenital, Heart & circulation clinical trials.
This trial tests a new type of plug that dissolves over time to close a specific type of hole in the heart (called an outlet VSD). The plug is placed during a procedure and aims to close the hole safely while keeping the nearby aortic valve working properly.
Summary written for real people, not researchers, by Clin2.
Who can take part
- The patient must be at least 1 year old and weigh at least 10 kg (about 22 pounds).
- The patient must have an outlet ventricular septal defect (a certain type of hole in the heart) that is not accompanied by misalignment of the heart's chambers.
- The largest width of the defect must be 12 mm or less, and the rim near the aortic valve must be very thin (1 mm or less).
- The patient must have no more than mild aortic regurgitation (leaking of the aortic valve).
- The patient must not have severe pulmonary hypertension (high blood pressure in the lungs), any blood clot in the heart, an active infection in the last month, or be pregnant.
- The patient (or guardian) must sign a written consent form agreeing to participate.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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