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EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03042104
Collaborator
(none)
901
Enrollment
77
Locations
2
Arms
175.6
Anticipated Duration (Months)
11.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Condition or Disease Intervention/Treatment Phase
  • Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
 N/A

Detailed Description

This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Study Design

Study Type:
Interventional
Actual Enrollment :
901 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Actual Study Start Date :
Jul 12, 2017
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAVR

Transcatheter aortic valve replacement (TAVR)

Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
Other Names:
  • SAPIEN 3, SAPIEN 3 Ultra

    		•
    No Intervention: CS

    Clinical surveillance (CS)

    Outcome Measures

    Primary Outcome Measures

    1. All-cause death, all stroke, and unplanned cardiovascular hospitalization [When all patients have reached 2-year follow-up]

      The number of patients that have any of these conditions

    Secondary Outcome Measures

    1. Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points [2 years]

      The number of patients that meet all of these criteria

    2. Left Ventricular Health [2 years]

      Echocardiographic measurements that will assess the health of the left ventricle

    3. Change in Left Ventricular Ejection Fraction (LVEF) [2 years]

      The average change in LVEF from baseline

    4. New onset atrial fibrillation [When all patients have reached 2-year follow-up]

      The number of patients that develop this condition

    5. Death or disabling stroke [When all patients have reached 2-year follow-up]

      The number of patients that have any of these conditions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 65 years of age or older

    2. Severe aortic stenosis

    3. Patient is asymptomatic

    4. LV ejection fraction ≥ 50%

    5. Society of Thoracic Surgeons (STS) risk score ≤ 10

    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. Patient is symptomatic

    2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.

    3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV

    4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.

    5. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR

    6. Evidence of an acute myocardial infarction ≤ 30 days before randomization

    7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified

    8. Severe aortic regurgitation (>3+)

    9. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis

    10. Pre-existing mechanical or bioprosthetic valve in any position

    11. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization

    12. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states

    13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization

    14. Hypertrophic cardiomyopathy with obstruction

    15. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

    16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy

    17. Stroke or transient ischemic attack within 90 days of randomization

    18. Renal insufficiency and/or renal replacement therapy

    19. Active bacterial endocarditis within 180 days of randomization

    20. Severe lung disease or currently on home oxygen

    21. Severe pulmonary hypertension

    22. History of cirrhosis or any active liver disease

    23. Significant frailty as determined by the Heart Team

    24. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system

    25. Patient refuses blood products

    26. BMI >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. Currently participating in an investigational drug or another device study.

    30. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center Phoenix Arizona United States 85006
    2 Mills Peninsula Health Services Burlingame California United States 94010
    3 Cedars-Sinai Medical Center Los Angeles California United States 90048
    4 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92663
    5 Huntington Hospital Pasadena California United States 91105
    6 UC Davis Medical Center Sacramento California United States 95817
    7 Kaiser San Francisco Medical Center San Francisco California United States 94115
    8 Stanford Hospital and Clinics Palo Alto Stanford California United States 94305
    9 UC Health Northern Colorado (Medical Center of the Rockies) Loveland Colorado United States 80538
    10 Yale University New Haven Connecticut United States 06510
    11 Washington Hospital Center DC Washington District of Columbia United States 20010
    12 The Cardiac & Vascular Institute Research Foundation Gainesville Florida United States 32605
    13 University of Florida Gainesville Florida United States 32615
    14 Piedmont Heart Institute Atlanta Georgia United States 30309
    15 Emory University Atlanta Georgia United States 30322
    16 Northwestern University Chicago Illinois United States 60611
    17 Rush University Medical Center Chicago Chicago Illinois United States 60612
    18 NorthShore University HealthSystem Research Institution Evanston Illinois United States 60201
    19 Alexian Brothers Hospital Network Lisle Illinois United States 60532
    20 Prairie Education and Research Cooperative Springfield Illinois United States 62701
    21 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    22 Iowa Heart Center West Des Moines Iowa United States 50266
    23 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67226
    24 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    25 Maine Medical Center Portland Maine United States 04102
    26 University of Maryland Medical Center Baltimore Maryland United States 21201
    27 Brigham and Women's Hospital Boston Massachusetts United States 02115
    28 Cape Cod Hospital Hyannis Massachusetts United States 02601
    29 Henry Ford Hospital Detroit Michigan United States 48202
    30 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
    31 University of Minnesota Medical Center Minneapolis Minnesota United States 55455
    32 Mayo Clinic Rochester Minnesota United States 55905
    33 CentraCare Heart Saint Cloud Minnesota United States 56303
    34 Saint Luke's Hospital of Kansas City Mid America Kansas City Missouri United States 64111
    35 St. Patrick Hospital Missoula Montana United States 59802
    36 Mary Hitchcock Memorial Hospital Lebanon New Hampshire United States 03756
    37 Atlantic Health System Hospital Corp - Morristown Medical Center Morristown New Jersey United States 07960
    38 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    39 Rutgers Robert Wood Johnson Medical School Piscataway New Jersey United States 08854
    40 Albany Medical College Albany New York United States 12211
    41 Montefiore Medical Center Bronx New York United States 10467
    42 University at Buffalo - Kaleida Health Buffalo New York United States 14203
    43 Winthrop University Hospital Mineola Mineola New York United States 11501
    44 New York University Langone Medical Center New York New York United States 10016
    45 Columbia University Medical Center/ New York Presbyterian Hospital New York New York United States 10032
    46 Cornell University New York New York United States 10065
    47 Rochester General Hospital Rochester New York United States 14621
    48 Stony Brook University Medical Center Stony Brook New York United States 11794
    49 Carolina's Health System Charlotte North Carolina United States 28203
    50 NC Heart and Vascular (Rex Hospital) Raleigh North Carolina United States 27607
    51 The Christ Hospital, Cincinnati Cincinnati Ohio United States 45219
    52 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    53 Mount Carmel Health System Columbus Ohio United States 43213
    54 The Ohio Health Research Institute Columbus Ohio United States 43214
    55 Kaiser Portland Clackamas Oregon United States 97015
    56 Pinnacle Health Harrisburg Pennsylvania United States 17101
    57 Allegheny - Singer Research Institute Pittsburgh Pennsylvania United States 15212
    58 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    59 York Hospital York Pennsylvania United States 17403
    60 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    61 The Heart Hospital Baylor Plano Dallas Texas United States 75093
    62 Texas Health Physician Group Dallas Texas United States 75231
    63 University of Texas Health Science Center at Houston Houston Texas United States 77030
    64 Intermountain Medical Center Salt Lake City Murray Utah United States 84107
    65 University of Virginia Charlottesville Virginia United States 22908
    66 Inova Heart and Vascular Institute (Fairfax Inova) Falls Church Virginia United States 22042
    67 Sentara Cardiovascular Research Institute Norfolk Virginia United States 23507
    68 Carilion Medical Center Roanoke Virginia United States 24014
    69 Providence Everett Everett Washington United States 98201
    70 Swedish Medical Center Seattle Washington United States 98122
    71 University of Washington Seattle Washington United States 98195
    72 Sacred Heart Medical Center Spokane Washington United States 99204
    73 CAMC Clinical Trials Center Charleston West Virginia United States 25304
    74 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    75 Hamilton Health Sciences Hamilton Ontario Canada L8L 2X2
    76 University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
    77 Toronto General Hospital Toronto Ontario Canada M5G2C4

    Sponsors and Collaborators

    • Edwards Lifesciences

    Investigators

    • Principal Investigator: Philippe Généreux, MD, Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edwards Lifesciences
    ClinicalTrials.gov Identifier:
    NCT03042104
    Other Study ID Numbers:
    • 2016-07
    First Posted:
    Feb 3, 2017
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Edwards Lifesciences
    Aortic valve
    Asymptomatic
    Transcatheter aortic valve replacement
    Additional relevant MeSH terms:
    Heart Diseases
    Aortic Valve Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Jan 24, 2022