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PARTNER 3 Trial - Mitral Valve in Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03193801
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
Safety and Effectiveness - composite of all-cause mortality and stroke [ Time Frame: 1 Year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Safety and Effectiveness - composite endpoint of all-cause mortality and stroke [ Time Frame: 1 Year ]
Non-hierarchical composite endpoint of all-cause mortality and stroke at 1 year post procedure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
  • New York Heart Association (NYHA) Functional Class [ Time Frame: 30 Days ]
    NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 30 days ]
    Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
  • Mitral regurgitation [ Time Frame: 30 days ]
    Change from baseline
  • Pulmonary artery systolic pressure [ Time Frame: 30 days ]
    Change from baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
New York Heart Association (NYHA) Functional Class [ Time Frame: 30 Days ]
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PARTNER 3 Trial - Mitral Valve in Valve
Official Title  ICMJE PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Valve Insufficiency
  • Mitral Valve Disease
  • Mitral Valve Regurgitation
  • Heart Failure
Intervention  ICMJE Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Other Name: TMVR
Study Arms  ICMJE Experimental: 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.
Intervention: Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2026
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwards THV Clinical Affairs (949) 250-2500 THV_CT.gov@Edwards.com
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03193801
Other Study ID Numbers  ICMJE 2015-08 MVIV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account Edwards Lifesciences
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP