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

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ClinicalTrials.gov Identifier: NCT03042104
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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
Heart Diseases Aortic Stenosis, Severe Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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 : July 12, 2017
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2032

Resource links provided by the National Library of Medicine


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 Name: SAPIEN 3, SAPIEN 3 Ultra

No Intervention: CS
Clinical surveillance (CS)



Primary Outcome Measures :
  1. All-cause death, all stroke, and unplanned cardiovascular hospitalization [ Time Frame: 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 [ Time Frame: 2 years ]
    The number of patients that meet all of these criteria

  2. Left Ventricular Health [ Time Frame: 2 years ]
    Echocardiographic measurements that will assess the health of the left ventricle

  3. Change in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 2 years ]
    The average change in LVEF from baseline

  4. New onset atrial fibrillation [ Time Frame: When all patients have reached 2-year follow-up ]
    The number of patients that develop this condition

  5. Death or disabling stroke [ Time Frame: When all patients have reached 2-year follow-up ]
    The number of patients that have any of these conditions



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03042104


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: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03042104    
Other Study ID Numbers: 2016-07
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: September 10, 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:
Aortic valve
Asymptomatic
Transcatheter aortic valve replacement
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Constriction, Pathologic
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction