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COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

NCT02744677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-03-06

No results posted yet for this study

Summary

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted 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

Interventions

DEVICE

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position

DEVICE

SAPIEN 3 THV

SAPIEN 3 THV in the pulmonic position

DEVICE

SAPIEN 3 Ultra RESILIA THV

SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • D. Scott Lim, MD · University of Virginia Medical Center

  • Vasilis Babaliaros, MD · Emory University Hospitals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-05
Primary Completion
2026-12-31
Completion
2031-06-30
FDA Device
Yes

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 NCT02744677 on ClinicalTrials.gov