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

Edwards Lifesciences

Status: Completed

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

Treatments: Device: SAPIEN XT THV

Study type: Observational

Funder types: Industry

Identifiers

NCT02987387

2015-10

Details and patient eligibility

About

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.

Full description

The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has a dysfunctional, non-compliant RVOT conduit.
2. 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

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

Trial design

57 participants in 1 patient group

TPVI

Description:

Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV

Treatment:

Device: SAPIEN XT THV