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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

NCT03130777 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-09-25

Study results available
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Summary

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Conditions

  • Pulmonary Disease
  • Transcatheter Pulmonary Valve Replacement (TPVR)
  • Tetralogy of Fallot
  • Congenital Heart Disease
  • Pulmonary Regurgitation

Interventions

DEVICE

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Evan Zahn, MD, FACC, FSCAI · Cedars-Sinai Heart Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2022-07-14
Completion
2032-06-30
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 NCT03130777 on ClinicalTrials.gov