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The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

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: NCT03471065
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: SAPIEN 3 Ultra System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 23, 2019
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR) Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.




Primary Outcome Measures :
  1. Procedural Success [ Time Frame: Day 0 ]

    Defined as freedom from all of the following at exit from the procedure room:

    • Mortality
    • Conversion to surgery
    • Moderate or severe paravalvular regurgitation


Secondary Outcome Measures :
  1. Major Vascular Complications [ Time Frame: Discharge ]
    Number of patients with major vascular complications

  2. Valve Migration or Embolization [ Time Frame: Discharge ]
    Number of patients with valve migration or embolization



Information from the National Library of Medicine

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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 meeting the following transthoracic echocardiogram criteria:

    • Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2
    • Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
  2. New York Heart Association functional class ≥ II
  3. Judged by the Heart Team to be at intermediate risk for open surgical therapy
  4. The subject 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 available THV sizes on 3D imaging analysis
  2. Aortic valve is unicuspid, bicuspid or non-calcified
  3. Pre-existing mechanical or bioprosthetic valve in any position.
  4. Severe aortic regurgitation (> 3+)
  5. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
  6. Ventricular dysfunction with left ventricular ejection fraction < 30%
  7. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  8. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
  9. Subjects with planned concomitant ablation for atrial fibrillation
  10. Hypertrophic cardiomyopathy with obstruction
  11. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
  12. Complex coronary artery disease:

    1. Unprotected left main coronary artery
    2. SYNTAX score > 32
    3. Heart Team assessment that optimal revascularization cannot be performed
  13. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath
  14. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
  15. Active bacterial endocarditis within 180 days of the valve implant procedure
  16. Stroke or transient ischemic attack within 90 days of the valve implant procedure
  17. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
  18. Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home oxygen
  19. Severe pulmonary hypertension
  20. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
  21. History of cirrhosis or any active liver disease
  22. Renal insufficiency and/or renal replacement therapy at the time of screening
  23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  24. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
  25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
  26. Significant frailty as determined by the Heart Team
  27. Subject refuses blood products
  28. Body mass index > 50 kg/m2
  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.

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): NCT03471065


Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec
Québec City, Quebec, Canada
United Kingdom
Kings Hospital
London, United Kingdom
St. Thomas Hospital
London, United Kingdom
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: John Webb, MD St. Paul's Hospital
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03471065    
Other Study ID Numbers: 2018-03
First Posted: March 20, 2018    Key Record Dates
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
Transcatheter
Transcatheter Valve Replacement
SAPIEN 3 Ultra
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction