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

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03471065

2018-03

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Transcatheter Aortic Valve Replacement (TAVR)

Experimental group

Treatment:

Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV