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Clinical Trials in the USA / NCT03193801
Active, not recruiting Not applicable

PARTNER 3 Trial - Mitral Valve in Valve

NCT03193801 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2018-02-01
Last updated
2025-11-05

Condition(s) studied

Mitral Valve InsufficiencyMitral Valve DiseaseMitral Valve RegurgitationHeart Failure

Investigational drug(s) / intervention(s)

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX: Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.

Study summary

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

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Emory University Atlanta Georgia
Northwestern University Chicago Illinois
Northshore University Health System Research Institution Evanston Illinois
Brigham and Women's Hospital Boston Massachusetts
Mayo Clinic Rochester Minnesota
Barnes-Jewish Hospital/ Washington University St Louis Missouri
NYU Lagone Medical Center New York New York
Providence Heart & Vascular Institution Portland Oregon
The Heart Hospital of Baylor Plano Plano Texas
The Prince Charles Hospital Chermside Queensland
Instituto do Coração da Universidade de São Paulo Cerqueira César São Paulo
Instituto Dante Pazzanese de Cardiologia Vila Mariana São Paulo

More Edwards Lifesciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03193801 on ClinicalTrials.gov ↗ ← All trials in the USA