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

NCT02987387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

SAPIEN XT THV

SAPIEN XT THV will be implanted in the pulmonic position.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2021-08-09
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987387 on ClinicalTrials.gov