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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Heart Defects, Congenital Congenital Abnormalities Cardiovascular Diseases Heart Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TPVI

Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV

SAPIEN XT THV

Intervention Type DEVICE

SAPIEN XT THV will be implanted in the pulmonic position.

Interventions

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SAPIEN XT THV

SAPIEN XT THV will be implanted in the pulmonic position.

Intervention Type DEVICE

Eligibility Criteria

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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.