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NCT Number: NCT02987387

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

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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Key information

Conditions

Pulmonary Valve Insufficiency Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Pulmonary Atresia Pulmonary Valve Stenosis Tetralogy of Fallot Vascular Malformations Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has a dysfunctional, non-compliant RVOT conduit.
  • 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

  • Inability to tolerate an anticoagulation/antiplatelet regimen
  • Active bacterial endocarditis

Treatment and study plan

SAPIEN XT THV

Device

SAPIEN XT THV will be implanted in the pulmonic position.

Primary outcomes

  1. Freedom from device- or procedure-related death or reintervention

    Time frame: 1 year

Secondary outcomes

  1. Decrease in pulmonary regurgitation to mild or less for regurgitant lesions

    Time frame: 1 year

    Assessed via transthoracic echocardiogram (TTE)

  2. Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions

    Time frame: 1 year

    Assessed via TTE

  3. Device Success

    Time frame: 48 Hours Prior to Discharge

    Device Success is a composite of:

    • Deployment of the valve to the target area, and
    • Removal of the delivery catheter out of the body, and
    • Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

New Enrollment SAPIEN XT Post-Approval Study

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
Dec 8, 2016
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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