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

Completed

Conditions studied: Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases

In brief

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.

Key facts

Study ID

NCT02987387

Run by

Edwards Lifesciences

People needed

57

Starts

2017-07-17

Expected to finish

2025-09-30

Last updated by the study team

2025-12-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has a dysfunctional, non-compliant RVOT conduit.
• 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.

You may not qualify if…

• Inability to tolerate an anticoagulation/antiplatelet regimen
• Active bacterial endocarditis

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Advocate Children's Hospital — Oak Lawn, Illinois, United States
• The University of Iowa — Iowa City, Iowa, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Heart Center Nevada — Las Vegas, Nevada, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Mount Sinai Beth Israel — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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