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

Aortic Valve Stenosis Clinical Trial

Official title:

A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03517436
• Other study ID #: 2017-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: July 2030

Study information

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

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: July 2030
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• TAVR with CENTERA THV
TAVR with the Edwards CENTERA THV System

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	The Ohio Health Research Institute	Columbus	Ohio
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Texas Memorial Hermann	Houston	Texas
United States	St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC	Indianapolis	Indiana
United States	University of Kansas Health System	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado
United States	Atlantic Health System Hospital Corp	Morristown	New Jersey
United States	Saint Thomas Health	Nashville	Tennessee
United States	Columbia University Medical Center/ NYPH	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny - Singer Research Institute	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Washington University/ Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Stanford University Medical Center	Stanford	California
United States	Baylor Scott and White, Central Texas	Temple	Texas
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death	Number of participants that died	1 year