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

Description

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.

Study Start Date

July, 17 2017

Estimated Completion Date

January 2024

Interventions

  • Device: SAPIEN XT THV

Study ID

Edwards Lifesciences -- 2015-10

Status

Recruiting

Trial ID

NCT02987387

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

191

Sponsor

Edwards Lifesciences

Inclusion Criteria

    1. Patient has a dysfunctional, non-compliant RVOT conduit. 2. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

    1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis

Gender

All

Ages

19 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (80)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Mount Sinai Beth Israel - New York, New York 187.6 miles None None None
Newark Beth Israel Medical Center - Newark, New Jersey 197.7 miles None None None
Childrens National Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, D.C., District of Columbia 391.7 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles None None None
UH Rainbow BabiesChildrens - Cleveland, Ohio 544.0 miles None None None
UH Rainbow BabiesChildrens - Cleveland, Ohio 544.0 miles None None None
UH Rainbow BabiesChildrens - Cleveland, Ohio 544.0 miles None None None
UH Rainbow BabiesChildrens - Cleveland, Ohio 544.0 miles None None None
UH Rainbow BabiesChildrens - Cleveland, Ohio 544.0 miles None None None
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles None None None
Childrens Hospital of Michigan - Detroit, Michigan 611.5 miles None None None
Childrens Hospital of Michigan - Detroit, Michigan 611.5 miles None None None
Childrens Hospital of Michigan - Detroit, Michigan 611.5 miles None None None
Childrens Hospital of Michigan - Detroit, Michigan 611.5 miles None None None
Childrens Hospital of Michigan - Detroit, Michigan 611.5 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 640.0 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital - Cincinnati, Ohio 735.6 miles None None None
Advocate Childrens Hospital - Oak Lawn, Illinois 856.5 miles None None None
Advocate Childrens Hospital - Oak Lawn, Illinois 856.5 miles None None None
Advocate Childrens Hospital - Oak Lawn, Illinois 856.5 miles None None None
Advocate Childrens Hospital - Oak Lawn, Illinois 856.5 miles None None None
Advocate Childrens Hospital - Oak Lawn, Illinois 856.5 miles None None None
The University of Iowa - Iowa City, Iowa 1,050.4 miles None None None
University of Alabama - Birmingham, Alabama 1,052.1 miles None None None
Nicklaus Childrens - Miami, Florida 1,265.3 miles None None None
Nicklaus Childrens - Miami, Florida 1,265.3 miles None None None
Nicklaus Childrens - Miami, Florida 1,265.3 miles None None None
Nicklaus Childrens - Miami, Florida 1,265.3 miles None None None
Nicklaus Childrens - Miami, Florida 1,265.3 miles None None None
Childrens Health Dallas - Dallas, Texas 1,551.5 miles None None None
Childrens Health Dallas - Dallas, Texas 1,551.5 miles None None None
Childrens Health Dallas - Dallas, Texas 1,551.5 miles None None None
Childrens Health Dallas - Dallas, Texas 1,551.5 miles None None None
Childrens Health Dallas - Dallas, Texas 1,551.5 miles None None None
Texas Childrens - Houston, Texas 1,609.9 miles None None None
Texas Childrens - Houston, Texas 1,609.9 miles None None None
Texas Childrens - Houston, Texas 1,609.9 miles None None None
Texas Childrens - Houston, Texas 1,609.9 miles None None None
Texas Childrens - Houston, Texas 1,609.9 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Heart Center Nevada - Las Vegas, Nevada 2,374.9 miles None None None
Childrens Heart Center Nevada - Las Vegas, Nevada 2,374.9 miles None None None
Childrens Heart Center Nevada - Las Vegas, Nevada 2,374.9 miles None None None
Childrens Heart Center Nevada - Las Vegas, Nevada 2,374.9 miles None None None
Childrens Heart Center Nevada - Las Vegas, Nevada 2,374.9 miles None None None
Rady Childrens Hospital - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital - San Diego, California 2,579.1 miles None None None
Rady Childrens Hospital - San Diego, California 2,579.1 miles None None None
Sutter Medical Center - Sacramento, California 2,595.9 miles MD None None
Sutter Medical Center - Sacramento, California 2,595.9 miles MD None None
Sutter Medical Center - Sacramento, California 2,595.9 miles MD None None
Sutter Medical Center - Sacramento, California 2,595.9 miles MD None None
Sutter Medical Center - Sacramento, California 2,595.9 miles MD None None

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