PARTNER 3 Trial - Mitral Valve in Valve

NCT03193801 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 2015-08 MVIV
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 12

Brief 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

Keywords

SAPIEN 3; PARTNER 3; cardiovascular disease; TMVR; failing valve; failing bioprosthetic valve

Outcome Measures

Primary Outcomes (1)

• Safety and Effectiveness - Composite of All-cause Mortality and Stroke

  Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure

  1 Year

Secondary Outcomes (4)

• New York Heart Association (NYHA) Functional Class - Change From Baseline

  30 Days

• Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline

  30 days

• Mitral Regurgitation - Change From Baseline

  30 days

• Pulmonary Artery Systolic Pressure - Change From Baseline

  30 days

Study Arms (1)

Failing mitral transcatheter valve

EXPERIMENTAL

Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.

Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Interventions

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX DEVICE

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

Also known as: TMVR

Failing mitral transcatheter valve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
• Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
• NYHA Functional Class ≥ II.
• Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and \< 8).
• Heart Team agrees valve implantation will likely benefit the patient.
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the respective clinical site.

You may not qualify if:

• Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact as determined by transesophageal echocardiography (TEE).
• Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
• Known residual mean gradient \>10 mmHg at the end of the index procedure for implantation of the original surgical valve.
• Severe right ventricle (RV) dysfunction.
• Anatomical characteristics that would preclude safe access to the apex (transapical).
• Severe regurgitation or stenosis of any other valve.
• Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen
• Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
• Anatomical characteristics that would increase risk of LVOT obstruction (e.g., aortomitral angle, LVOT size, etc.).
• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before enrollment.
• Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
• Leukopenia (white blood count \< 3000 cell/mL), anemia (hemoglobin \< 9 g/dL), thrombocytopenia (blood platelet count \< 50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment.
• Emergency intervention/surgical procedures within one month (30 days) prior to the procedure.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (12)

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northshore University Health System Research Institution

Evanston, Illinois, 60201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital/ Washington University

St Louis, Missouri, 63110, United States

Location

NYU Lagone Medical Center

New York, New York, 10016, United States

Location

Providence Heart & Vascular Institution

Portland, Oregon, 97225, United States

Location

The Heart Hospital of Baylor Plano

Plano, Texas, 75093, United States

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Instituto do Coração da Universidade de São Paulo

Cerqueira César, São Paulo, 05403-900, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

Vila Mariana, São Paulo, 04012-909, Brazil

Location

Related Publications (1)

• Malaisrie SC, Guerrero M, Davidson C, Williams M, de Brito FS Jr, Abizaid A, Shah P, Kaneko T, Poon K, Levisay J, Yu X, Pibarot P, Hahn RT, Blanke P, Leon MB, Mack MJ, Zajarias A; PARTNER 3 Mitral Valve-in-Valve Study Investigators. One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients. Circ Cardiovasc Interv. 2024 Aug;17(8):e013782. doi: 10.1161/CIRCINTERVENTIONS.123.013782. Epub 2024 Jul 22.

  PMID: 39034924 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases

Results Point of Contact

• Title: Director of Research
• Organization: Edwards Lifesciences

THV_ct.gov@edwards.com

949-250-2500

Study Officials

• Mayra Guerrero, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Chris S. Malaisrie, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Alan Zajarias, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: February 1, 2018
• Primary Completion: August 16, 2022
• Study Completion (Estimated): August 1, 2031
• Last Updated: November 5, 2025
• Results First Posted: October 24, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BR (2); US (9)