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

Status:	Active, not recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	9/8/2018
Start Date:	July 5, 2016
End Date:	December 2022

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards
Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal
of 25% 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.

The purpose of this study is to demonstrate the safety and effectiveness of the Edwards
Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously
implanted valve in the pulmonic position with a clinical indication for intervention.

Inclusion Criteria:

- Weight ≥ 20 kg (44 lbs.)

- Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.

- The subject/subject'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:

- Active infection requiring current antibiotic therapy (if temporary illness, subject
may be a candidate 2 weeks after discontinuation of antibiotics)

- History of or active endocarditis (active treatment with antibiotics) within the past
180 days

- Leukopenia (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets <
50,000 cells/µL) or any known blood clotting disorder

- Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV

We found this trial at

sites

University of Kentucky

Lexington, Kentucky

859) 257-9000