CompletedNot Applicable

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

United States57 participantsStarted 2017-07-17

Plain-language summary

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.

Who can participate

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Freedom from device- or procedure-related death or reintervention

Timeframe: 1 year

Trial details

NCT IDNCT02987387

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-08-09

View on ClinicalTrials.gov More Pulmonary Valve Insufficiency trials