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PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675114
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Results First Posted : December 2, 2021
Last Update Posted : November 30, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Procedure: SAVR Device: SAPIEN 3 THV Not Applicable

Detailed Description:

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 16, 2020
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Surgical aortic valve replacement (SAVR) Procedure: SAVR
SAVR with a commercially available bioprosthetic valve.
Experimental: Transcatheter aortic valve replacement (TAVR) Device: SAPIEN 3 THV
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System


Outcome Measures
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Primary Outcome Measures :
  1. All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) [ Time Frame: 1 year ]
    Number of patients that had any of these events


Secondary Outcome Measures :
  1. New Onset Atrial Fibrillation [ Time Frame: 30 days ]
    Number of patients with this event

  2. Length of Index Hospitalization [ Time Frame: Discharge (expected average of 7 days) ]
    Number of days from index procedure to discharge

  3. Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points [ Time Frame: 30 days ]
    Number of patients that had any of these events

  4. Death or Stroke [ Time Frame: 30 days ]
    Number of patients that died or had a stroke

  5. All Stroke [ Time Frame: 30 days ]
    Number of patients that had a stroke


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. Severe, calcific aortic stenosis
  2. New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%
  3. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4
  4. 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. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
  2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
  3. Evidence of an acute myocardial infarction ≤ 30 days before randomization
  4. Aortic valve is unicuspid, bicuspid, or non-calcified
  5. Severe aortic regurgitation (>3+)
  6. Severe mitral regurgitation (>3+) ≥ moderate stenosis
  7. Pre-existing mechanical or bioprosthetic valve in any position

  8. Complex coronary artery disease:

    1. Unprotected left main coronary artery
    2. Syntax score > 32
    3. Heart Team assessment that optimal revascularization cannot be performed
  9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
  10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
  11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
  12. Hypertrophic cardiomyopathy with obstruction
  13. Ventricular dysfunction with LVEF < 30%
  14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  15. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  16. Stroke or transient ischemic attack within 90 days of randomization
  17. Renal insufficiency and/or renal replacement therapy at the time of screening.
  18. Active bacterial endocarditis within 180 days of randomization
  19. Severe lung disease or currently on home oxygen
  20. Severe pulmonary hypertension
  21. History of cirrhosis or any active liver disease
  22. Significant frailty as determined by the Heart Team
  23. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement
  24. Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
  25. Patient refuses blood products
  26. Body mass index > 50 kg/m2
  27. Estimated life expectancy < 24 months
  28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
  29. Immobility that would prevent completion of study procedures
  30. Patient is not a candidate for both arms of the study
  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): NCT02675114


Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Martin B Leon, MD, FACC Columbia University Medical Center/ New York Presbyterian Hospital, NY
Principal Investigator: Michael J Mack, MD, FACC The Heart Hospital Baylor Plano, TX
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Study Protocol and Statistical Analysis Plan  [PDF] December 1, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02675114    
Other Study ID Numbers: 2015-08
First Posted: February 5, 2016    Key Record Dates
Results First Posted: December 2, 2021
Last Update Posted: November 30, 2023
Last Verified: November 2023
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
cardiovascular disease
heart disease
 aortic stenosis
Surgical aortic valve replacement (SAVR)
Transcatheter aortic valve replacement (TAVR)
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