Last updated on October 2017

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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Erika Tequia

University of Alabama
Birmingham, AL United States
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, MD

Sutter Medical Center
Sacramento, CA United States
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Erika Tequia

Rady Children's Hospital
San Diego, CA United States
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Erika Tequia

Children's Hospital Colorado
Aurora, CO United States
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Erika Tequia

Children's National Medical Center
Washington, D.C., United States
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Erika Tequia

Nicklaus Children's
Miami, FL United States
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Erika Tequia

Advocate Children's Hospital
Oak Lawn, IL United States
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Erika Tequia

The University of Iowa
Iowa City, IA United States
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Erika Tequia

Boston Children's Hospital
Boston, MA United States
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Erika Tequia

Children's Hospital of Michigan
Detroit, MI United States
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Erika Tequia

Children's Heart Center Nevada
Las Vegas, NV United States
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Erika Tequia

Newark Beth Israel Medical Center
Newark, NJ United States
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Erika Tequia

Mount Sinai Beth Israel
New York, NY United States
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Erika Tequia

Cincinnati Children's Hospital
Cincinnati, OH United States
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Erika Tequia

UH Rainbow Babies&Children's
Cleveland, OH United States
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Erika Tequia

Cleveland Clinic Foundation
Cleveland, OH United States
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Erika Tequia

Nationwide Children's Hospital
Columbus, OH United States
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Erika Tequia

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA United States
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Erika Tequia

Children's Health Dallas
Dallas, TX United States
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Erika Tequia

Texas Children's
Houston, TX United States
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