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PARTNER 3 Trial - Mitral Valve in Valve

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ClinicalTrials.gov Identifier: NCT03193801
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Mitral Valve Disease Mitral Valve Regurgitation Heart Failure Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2031

Arm Intervention/treatment
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.
Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Other Name: TMVR




Primary Outcome Measures :
  1. Safety and Effectiveness - composite of all-cause mortality and stroke [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. 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.

  2. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 30 days ]
    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom, social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  3. Mitral regurgitation [ Time Frame: 30 days ]
    Echocardiographic assessment of the degree of mitral valve regurgitation

  4. Pulmonary artery systolic pressure [ Time Frame: 30 days ]
    Echocardiographic assessment of pulmonary artery systolic pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193801


Locations
Show Show 17 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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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
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03193801    
Other Study ID Numbers: 2015-08 MVIV
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
SAPIEN 3
PARTNER 3
cardiovascular disease
TMVR
failing valve
failing bioprosthetic valve
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases