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COMPASSION S3 Post-Approval Study

NCT04860765 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-02-03

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

SAPIEN 3 THV

SAPIEN 3 THV in the pulmonic position

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2030-08-31
Completion
2030-08-31

Countries

  • United States

Study Locations

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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 NCT04860765 on ClinicalTrials.gov