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PARTNER 3 Trial - Aortic 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: NCT03003299
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Aortic Stenosis, Severe Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV Not Applicable

Detailed Description:
This is a prospective, single-arm, multicenter study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : January 2033
Estimated Study Completion Date : April 2038

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAVR - Failing surgical or transcatheter valve
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
 Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mean gradient [ Time Frame: 30 days ]
    Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.

  2. Peak gradient [ Time Frame: 30 days ]
    Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT03003299


Contacts
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Contact: Edwards THV Clinical Affairs (949) 250-2500 THV_CT.gov@Edwards.com

Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Chris S Malaisrie, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Alan Zajarias, MD Washington University School of Medicine
Principal Investigator: Mayra Guerrero, MD Mayo Clinic
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03003299    
Other Study ID Numbers: 2015-08 AVIV
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
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
heart disease
aortic stenosis
SAVR
 TAVR
failing surgical valve
failing bioprosthetic valve
failing valve
SAPIEN 3 Ultra
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction