ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
NCT ID: NCT03517436
Last Updated: 2025-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
101 participants
INTERVENTIONAL
2018-09-18
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcatheter Aortic Valve Replacement (TAVR)
TAVR with CENTERA THV
TAVR with the Edwards CENTERA THV System
Interventions
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TAVR with CENTERA THV
TAVR with the Edwards CENTERA THV System
Eligibility Criteria
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Inclusion Criteria
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
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
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center/ NYPH
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, 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
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, United States
Atlantic Health System Hospital Corp
Morristown, New Jersey, United States
Columbia University Medical Center/ NYPH
New York, New York, United States
The Ohio Health Research Institute
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, United States
Saint Thomas Health
Nashville, Tennessee, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas Memorial Hermann
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Baylor Scott and White, Central Texas
Temple, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-18
Identifier Type: -
Identifier Source: org_study_id