PARTNER 3 Trial - Mitral Valve in Valve

NCT ID: NCT03193801

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2031-08-31

Brief Summary

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

Detailed Description

A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).

Conditions

Mitral Valve Insufficiency; Mitral Valve Disease; Mitral Valve Regurgitation; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Failing mitral transcatheter valve

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

Group Type: EXPERIMENTAL

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Intervention Type: DEVICE

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

Interventions

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

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

Intervention Type: DEVICE

Other Intervention Names

TMVR

Eligibility Criteria

Inclusion Criteria

1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

2. Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.

3. NYHA Functional Class ≥ II.

4. Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and < 8).

5. Heart Team agrees valve implantation will likely benefit the patient.

6. 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.

Exclusion Criteria

1. 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).

2. Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.

3. Known residual mean gradient >10 mmHg at the end of the index procedure for implantation of the original surgical valve.

4. Severe right ventricle (RV) dysfunction.

5. Anatomical characteristics that would preclude safe access to the apex (transapical).

6. Severe regurgitation or stenosis of any other valve.

7. Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen

8. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)

9. Anatomical characteristics that would increase risk of LVOT obstruction (e.g., aortomitral angle, LVOT size, etc.).

10. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before enrollment.

11. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD) is not considered an exclusion.

12. Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.

13. 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.

14. Untreated clinically significant coronary artery disease requiring revascularization.

15. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment.

16. Emergency intervention/surgical procedures within one month (30 days) prior to the procedure.

17. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure.

18. Hypertrophic cardiomyopathy with obstruction (HOCM).

19. Left ventricular ejection fraction (LVEF) < 30%.

20. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.

21. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure.

22. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication.

23. Stroke or transient ischemic attack (TIA) within 90 days of enrollment.

24. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment.

25. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening.

26. Active bacterial endocarditis within 6 months (180 days) of the procedure.

27. Patient refuses blood products.

28. Estimated life expectancy < 24 months.

29. Currently participating in an investigational drug or another device study. Note: Clinical trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.

30. Positive urine or serum pregnancy test in female subjects of childbearing potential.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mayra Guerrero, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Chris S. Malaisrie, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Alan Zajarias, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Northshore University Health System Research Institution

Evanston, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Barnes-Jewish Hospital/ Washington University

St Louis, Missouri, United States

NYU Lagone Medical Center

New York, New York, United States

Providence Heart & Vascular Institution

Portland, Oregon, United States

The Heart Hospital of Baylor Plano

Plano, Texas, United States

The Prince Charles Hospital

Chermside, Queensland, Australia

Instituto do Coração da Universidade de São Paulo

Cerqueira César, São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

Vila Mariana, São Paulo, Brazil

Countries

United States; Australia; Brazil

References

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.

Reference Type: DERIVED

PMID: 39034924 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-08 MVIV

Identifier Type: -

Identifier Source: org_study_id