Clinical trial NCT03517436: ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: THV
Transcatheter Heart Valve
CENTERA
self-expanding
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-05-07
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: 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

Primary outcomes:
measure: All-cause Death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Loveland
country: United States
facility: UC Health Northern Colorado (Medical Center of the Rockies)
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University/ Barnes-Jewish Hospital
state: Missouri
city: Morristown
country: United States
facility: Atlantic Health System Hospital Corp
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/ NYPH
state: New York
city: Columbus
country: United States
facility: The Ohio Health Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny - Singer Research Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: University of Texas Memorial Hermann
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White, Central Texas
state: Texas
Study officials:
affiliation: Columbia University Medical Center/ NYPH
name: Martin Leon, MD
role: PRINCIPAL_INVESTIGATOR
References: