New heart valve passes safety check in 57 patients
NCT ID NCT02987387
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the SAPIEN XT heart valve, which is placed through a thin tube (catheter) to fix a failed valve in the heart's right ventricle. Researchers wanted to confirm it is safe and works well. They enrolled 57 people with a narrowed or leaky heart valve conduit. The main goal was to see if the valve prevented death or the need for another procedure.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- SAPIEN XT Transcatheter Heart Valve (a replacement heart valve delivered through a catheter)
- What this could lead to
- If successful, this confirms a less invasive option for replacing a failed heart valve conduit, reducing the need for open-heart surgery.
- What could go wrong
- This is a post-approval study with a small number of participants (57), so results may not apply to all patients. Risks include bleeding, infection, or the valve not working as intended.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advocate Children's Hospital
Oak Lawn, Illinois, 60453, United States
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Children's Heart Center Nevada
Las Vegas, Nevada, 89109, United States
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
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Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Mount Sinai Beth Israel
New York, New York, 10003, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
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The University of Iowa
Iowa City, Iowa, 52242, United States
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University of Alabama
Birmingham, Alabama, 35294, United States
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