Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date September 10, 2021
Actual Study Start Date  ICMJE July 12, 2017
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
Non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization. [ Time Frame: 2 years ]
This measure is a non-hierarchical composite of any of the following events: all-cause death or stroke or unplanned cardiovascular hospitalization. For the analysis, the trial arms will be compared using the log-rank test at α=0.05.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
  • 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
  • Left Ventricular Health [ Time Frame: 2 years ]
    Echocardiographic measurements that will assess the health of the left ventricle
  • Change in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 2 years ]
    The average change in LVEF from baseline
  • New onset atrial fibrillation [ Time Frame: When all patients have reached 2-year follow-up ]
    The number of patients that develop this condition
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
Death or disabling stroke [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Official Title  ICMJE Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Diseases
  • Aortic Stenosis, Severe
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: TAVR
    Transcatheter aortic valve replacement (TAVR)
    Intervention: Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
  • No Intervention: CS
    Clinical surveillance (CS)
Publications * Zelis JM, Tonino PAL, Pijls NHJ, De Bruyne B, Kirkeeide RL, Gould KL, Johnson NP. Coronary Microcirculation in Aortic Stenosis: Pathophysiology, Invasive Assessment, and Future Directions. J Interv Cardiol. 2020 Jul 22;2020:4603169. doi: 10.1155/2020/4603169. eCollection 2020. Review.

*   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: September 2, 2021)
900
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
1109
Estimated Study Completion Date  ICMJE March 2032
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (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 NCT03042104
Other Study ID Numbers  ICMJE 2016-07
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: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
PRS Account Edwards Lifesciences
Verification Date September 2021

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