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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03471065
• Other study ID #: 2018-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Québec City	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United Kingdom	Kings Hospital	London
United Kingdom	St. Thomas Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Success	The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: Mortality; Conversion to surgery; Moderate or severe paravalvular regurgitation	Day 0
Secondary	Major Vascular Complications	Number of patients with major vascular complications	Discharge, expected to be within 1-5 days post-procedure]
Secondary	Valve Migration or Embolization	Number of patients with valve migration or embolization	Discharge, expected to be within 1-5 days post-procedure]