Clinical trial NCT03471065: The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter
Transcatheter Valve Replacement
SAPIEN 3 Ultra
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SAPIEN 3 Ultra System
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Procedural Success
timeFrame: Day 0
Secondary outcomes:
measure: Major Vascular Complications
timeFrame: Discharge, expected to be within 1-5 days post-procedure]
measure: Valve Migration or Embolization
timeFrame: Discharge, expected to be within 1-5 days post-procedure]
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Québec City
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
city: London
country: United Kingdom
facility: Kings Hospital
city: London
country: United Kingdom
facility: St. Thomas Hospital
Study officials:
affiliation: St. Paul's Hospital
name: John Webb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Thomas Hospital
name: Bernard Prendergast, Prof
role: PRINCIPAL_INVESTIGATOR
References: