ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis

Treatments: Device: TAVR with CENTERA THV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03517436

2017-18

Details and patient eligibility

About

This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).

Full description

A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.

Enrollment: 101 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Severe, calcific AS
2. NYHA 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 sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis
2. Aortic valve is unicuspid, bicuspid or non-calcified
3. Pre-existing mechanical or bioprosthetic valve in any position
4. Known hypersensitivity to Nitinol (nickel or titanium)
5. Severe aortic regurgitation (> 3+)
6. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
7. Ventricular dysfunction with left ventricular ejection fraction < 30%
8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
9. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
10. Subjects with planned concomitant ablation for atrial fibrillation
11. Hypertrophic cardiomyopathy with obstruction
12. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
13. Complex coronary artery disease
14. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
15. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
16. Active bacterial endocarditis within 180 days of the valve implant procedure
17. Stroke or transient ischemic attack within 90 days of the valve implant procedure
18. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
19. Severe lung disease or currently on home oxygen
20. Severe pulmonary hypertension
21. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
22. History of cirrhosis or any active liver disease
23. Renal insufficiency and/or renal replacement therapy at the time of screening
24. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
25. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
26. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
27. Significant frailty as determined by the Heart Team
28. Immobility that would prevent completion of study procedures
29. Subject refuses blood products
30. Body mass index > 50 kg/m2
31. Estimated life expectancy < 24 months
32. Positive urine or serum pregnancy test in female subjects of childbearing potential
33. 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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101 participants in 1 patient group

Transcatheter Aortic Valve Replacement (TAVR)

Experimental group

Treatment:

Device: TAVR with CENTERA THV