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PARTNER 3 Trial - Aortic Valve-in-Valve

NCT03003299 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-05-10

No results posted yet for this study

Summary

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Conditions

  • Aortic Stenosis
  • Aortic Stenosis, Severe

Interventions

DEVICE

Edwards SAPIEN 3/SAPIEN 3 Ultra THV

Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Chris S Malaisrie, MD · Northwestern University Feinberg School of Medicine

  • Alan Zajarias, MD · Washington University School of Medicine

  • Mayra Guerrero, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2033-01-31
Completion
2038-04-30
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03003299 on ClinicalTrials.gov