COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Recruiting N/A Interventional Study
Complex Congenital Heart Defect Dysfunctional RVOT Conduit Pulmonary Valve Insufficiency Pulmonary Valve Degeneration
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
Edwards Lifesciences · Industry
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About This Trial

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Weight ≥ 20 kg (44 lbs.) 2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions…
Contacts

Edwards THV Clinical Affairs

(949) 250-2500

THV_CT.gov@Edwards.com

CONTACT