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PARTNER 3 Trial - Aortic Valve-in-Valve (P3-AVIV)

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: NCT03003299
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE December 19, 2016
First Posted Date  ICMJE December 28, 2016
Last Update Posted Date November 26, 2021
Actual Study Start Date  ICMJE January 5, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2020)
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke [ Time Frame: 1 year ]
Number of patients that died and/or had a stroke
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
Safety and Effectiveness - composite endpoint of all-cause mortality and stroke [ Time Frame: 1 year ]
Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications. Measured in %.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2020)
  • Mean gradient [ Time Frame: 30 days ]
    Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
  • Peak gradient [ Time Frame: 30 days ]
    Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
  • 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.
  • New York Heart Association (NYHA) Classification [ Time Frame: 30 days ]
    Change from baseline in NYHA. 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.
  • Six-Minute Walk Test (6MWT) [ Time Frame: 30 days ]
    Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
  • Mean gradient [ Time Frame: 30 days ]
    Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
  • New York Heart Association (NYHA) Classification [ Time Frame: 30 days ]
    NYHA provides a way of classifying the extent of heart failure. New York Heart Association (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 - Aortic Valve-in-Valve
Official Title  ICMJE A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
Brief Summary This study will assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing aortic surgical or transcatheter bioprosthetic valve.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Stenosis
  • Cardiomyopathy, Hypertrophic
Intervention  ICMJE Device: Edwards SAPIEN 3 THV
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Study Arms  ICMJE
  • Experimental: TAVR - Failing surgical valve
    Patients with a failing surgical bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
    Intervention: Device: Edwards SAPIEN 3 THV
  • Experimental: TAVR - Failing transcatheter valve
    Patients with a failing transcatheter bioprosthetic valve will undergo TAVR.
    Intervention: Device: Edwards SAPIEN 3 THV
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: December 21, 2016)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2027
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
  3. NYHA Functional Class ≥ II.
  4. Heart Team agrees the patient is low to intermediate risk.
  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.

Exclusion Criteria:

  1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
  2. Severe regurgitation (> 3+) or stenosis of any other valve
  3. Failing valve has moderate or severe paravalvular regurgitation
  4. Failing valve is unstable, rocking, or not structurally intact
  5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  6. Increased risk of embolization of THV
  7. Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
  8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
  9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
  10. Anatomical characteristics that would preclude safe access to the apex (Transapical)
  11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment
  12. 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 or implantable cardioverter defibrillator is not considered an exclusion.
  13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
  14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  15. Untreated clinically significant coronary artery disease requiring revascularization
  16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
  17. Emergency interventional/surgical procedures within 30 days prior to the procedure
  18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
  19. Hypertrophic cardiomyopathy with obstruction
  20. LVEF < 30%
  21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  22. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  24. Stroke or transient ischemic attack within 90 days of enrollment
  25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
  26. Renal insufficiency and/or renal replacement therapy at the time of screening
  27. Active bacterial endocarditis within 180 days of the procedure
  28. Patient refuses blood products
  29. Estimated life expectancy < 24 months
  30. Positive urine or serum pregnancy test in female subjects of childbearing potential
  31. Currently participating in an investigational drug or another device study
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03003299
Other Study ID Numbers  ICMJE 2015-08 AVIV
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: 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 November 2021

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