Last updated on February 2018

COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

Brief description of study

This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

Detailed Study Description

The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of 35 mmHg by TTE.

Clinical Study Identifier: NCT02987387

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University of Alabama

Birmingham, AL United States
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Sutter Medical Center

Sacramento, CA United States
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Rady Children's Hospital

San Diego, CA United States
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Children's National Medical Center

Washington, D.C., United States
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Nicklaus Children's

Miami, FL United States
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Advocate Children's Hospital

Oak Lawn, IL United States
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The University of Iowa

Iowa City, IA United States
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Children's Heart Center Nevada

Las Vegas, NV United States
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Mount Sinai Beth Israel

New York, NY United States
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Cincinnati Children's Hospital

Cincinnati, OH United States
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UH Rainbow Babies&Children's

Cleveland, OH United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Children's Health Dallas

Dallas, TX United States
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Texas Children's

Houston, TX United States
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Recruitment Status: Open

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