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PARTNER 3 Trial - Mitral Valve in Valve

NCT03193801 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-11-05

Study results available
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Summary

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Conditions

  • Mitral Valve Insufficiency
  • Mitral Valve Disease
  • Mitral Valve Regurgitation
  • Heart Failure

Interventions

DEVICE

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Mayra Guerrero, MD · Mayo Clinic

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

  • Alan Zajarias, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2022-08-16
Completion
2031-08-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT03193801 on ClinicalTrials.gov