COMPASSION S3 Post-Approval Study

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Complex Congenital Heart Defect; Pulmonary Valve; Obstruction; Pulmonary Valve Degeneration; Dysfunctional RVOT Conduit; Pulmonary Valve Insufficiency

Treatments: Device: SAPIEN 3 THV

Study type: Observational

Funder types: Industry

Identifiers

NCT04860765

2020-07

Details and patient eligibility

About

This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Full description

This is a single arm, prospective, multicenter post-approval study.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Dysfunctional RVOT conduit or previously implanted surgical valve
2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Exclusion criteria

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis or other active infections

Trial design

150 participants in 1 patient group

TPVR

Description:

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Treatment:

Device: SAPIEN 3 THV