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ALTERRA Post-Approval Study

NCT05378386 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-11-04

No results posted yet for this study

Summary

This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting

Conditions

  • Pulmonary Valve Insufficiency
  • Complex Congenital Heart Defect
  • Tetralogy of Fallot
  • Pulmonary Regurgitation
  • RVOT Anomaly

Interventions

DEVICE

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV).

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2025-09-25
Completion
2035-07-31

Countries

  • United States
  • Israel

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 NCT05378386 on ClinicalTrials.gov